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Regulatory Disclaimer

Effective Date: July 17, 2026

Wasabi Method, LLC (“Wasabi Method,” “we,” “our,” or “us”) respects your privacy and is committed to protecting the personal information you provide when visiting wasabimethod.com (hereafter ‘the site’ or ‘website’), or purchasing products and services from us.

By using this website you acknowledge that you have read and agree to this Policy.

This Regulatory Disclaimer forms part of the legal terms governing access to and use of Wasabi Method websites, products, services, memberships, courses, events, professional resources, and related content. The term “Policy” in the acknowledgment above refers to this Regulatory Disclaimer and any related legal policies incorporated by reference.

1. Purpose and Scope

This Regulatory Disclaimer applies to content and services made available by or through Wasabi Method, including:

  • Website pages, articles, news posts, and clinical resources
  • Professional courses, educational programs, and certifications
  • Membership content and gated resources
  • Live and recorded webinars
  • Conferences, summits, seminars, and in-person training
  • Clinical protocols, treatment examples, and procedural demonstrations
  • Research summaries, literature reviews, and educational commentary
  • Provider directories and professional listings
  • Medical-device descriptions, comparisons, and technical discussions
  • Videos, graphics, downloadable materials, and presentation slides
  • Artificial intelligence-assisted content and interactive tools
  • Products and services offered through Wasabi Method websites or affiliated platforms

This Disclaimer applies to wasabimethod.com, wasabimethod.store, wasabimethod.com.au, shockwavesummit2026.com, adam-gavine.carrd.co, and other websites, learning platforms, applications, portals, or services operated by or on behalf of Wasabi Method.

2. Educational Use Only

Wasabi Method is a health-tech education company that provides professional education and general information for healthcare professionals, researchers, educators, healthcare organizations, business owners, and other qualified users.

Wasabi Method content is provided solely for educational and informational purposes. It is not:

  • Regulatory advice
  • Legal advice
  • Medical advice
  • Clinical advice for an individual patient
  • Licensing or scope-of-practice advice
  • Reimbursement, billing, or coding advice
  • Risk-management advice
  • Import, export, or distribution advice
  • Medical-device registration or market-access advice
  • A substitute for consultation with a qualified professional

Content presented by Wasabi Method, its CEO Adam Gavine, BHK, M.Chiro, its officers, faculty, contributors, sponsors, or partners is not a substitute for professional medical advice, diagnosis, treatment, emergency assessment, or individualized care from a qualified healthcare professional.

No clinical, commercial, regulatory, educational, or patient outcome is promised or guaranteed.

3. No Regulatory Approval or Endorsement

Wasabi Method is not a government agency, notified body, approved body, conformity-assessment body, standards organization, licensing board, or medical-device regulator.

Wasabi Method does not approve, clear, authorize, certify, include, register, list, license, classify, inspect, or grant market access to medical devices, manufacturers, distributors, healthcare facilities, practitioners, services, or clinical indications.

References to any of the following do not imply endorsement, approval, sponsorship, recommendation, or verification by the relevant authority:

  • A regulatory authority
  • A device registration or listing
  • A marketing authorization
  • A clearance or approval
  • An emergency or special authorization
  • A conformity assessment
  • CE marking
  • Inclusion in a regulatory register
  • An establishment licence
  • A manufacturer or facility registration
  • A product classification

Terms such as “FDA cleared,” “FDA approved,” “FDA authorized,” “FDA registered,” and “FDA listed” have different meanings and should not be used interchangeably. Registration or listing generally does not, by itself, mean that the United States Food and Drug Administration has reviewed, cleared, approved, certified, or endorsed a specific device.

Similarly, CE marking is a conformity marking and should not be described as “CE MDR approval.” Regulation (EU) 2017/745 is the European Union Medical Device Regulation, commonly referred to as the EU MDR. CE marking and compliance with the EU MDR are related but distinct regulatory concepts.

4. Jurisdiction-Specific Regulatory Authorities

Medical-device regulation varies substantially among jurisdictions. Depending on the product, location, intended purpose, supply chain, and proposed activity, relevant authorities and frameworks may include:

The MHRA regulates medical devices in the United Kingdom. Access to the European Union market is governed by the EU MDR, applicable national law, conformity-assessment requirements, and CE-marking requirements.

Regulatory terminology, legal requirements, transition arrangements, enforcement practices, and market-access pathways differ among foreign jurisdictions and may change without notice.

5. Regulatory Status Varies by Device and Market

The regulatory status of a medical device is specific to the product, manufacturer, intended purpose, model, configuration, labeling, jurisdiction, and applicable regulatory pathway.

The same or similar product may have different:

  • Regulatory classifications
  • Approved, cleared, licensed, or authorized indications
  • Intended uses or intended purposes
  • Models, versions, and configurations
  • Software versions
  • Accessories, applicators, handpieces, or components
  • Warnings, contraindications, and precautions
  • Labeling and instructions for use
  • Training requirements
  • Marketing and advertising permissions
  • Importation and distribution requirements
  • Commercial availability

A device lawfully marketed, registered, listed, licensed, cleared, approved, authorized, or supplied in one country may not have the same status in another country.

A device available for purchase online, displayed at an event, included in a directory, discussed in a course, or referenced by a Wasabi Method contributor should not be assumed to be lawfully authorized, registered, included, licensed, or commercially available in the user’s jurisdiction.

6. Intended Use, Intended Purpose, and Indications for Use

The legally relevant intended use, intended purpose, or indications for use of a medical device are generally established through the manufacturer’s authorized or current documentation. Depending on the jurisdiction, this documentation may include:

  • Product labeling
  • Instructions for use
  • Operator manuals
  • Technical documentation
  • Regulatory submissions and decisions
  • Advertising and promotional materials
  • Specifications and manufacturer-provided information

Descriptions, protocols, research summaries, comparisons, or clinical discussions published by Wasabi Method do not modify the manufacturer’s stated intended purpose, expand an authorized indication, or establish a new lawful use.

Users must identify the exact device, model, configuration, software version, accessory, applicator, manufacturer, and jurisdiction before determining the applicable regulatory status and authorized labeling.

7. Off-Label and Unapproved Uses

Wasabi Method content may discuss scientific research, emerging applications, clinical practices, investigational techniques, or uses that are outside a product’s authorized labeling in one or more jurisdictions.

Such discussion:

  • Does not establish regulatory clearance, approval, authorization, registration, licensing, inclusion, or conformity
  • Does not constitute a recommendation to use a device outside its authorized labeling
  • Does not establish that a use is lawful or within a practitioner’s scope of practice
  • Does not establish that a product may be advertised or promoted for that use
  • Does not mean that reimbursement is available
  • Does not mean that a use represents the applicable standard of care

Off-label use of a lawfully marketed product is distinct from the commercial supply or clinical use of a device that is not approved, cleared, authorized, licensed, included, registered, or otherwise lawfully marketed in the relevant jurisdiction.

Rules governing off-label clinical decisions, manufacturer promotion, distributor communications, advertising, research, informed consent, professional practice, reimbursement, and institutional approval vary by jurisdiction.

Healthcare professionals, manufacturers, distributors, researchers, and facility operators must obtain appropriate legal, regulatory, institutional, and professional guidance before relying upon an off-label, investigational, emerging, or unapproved application.

8. Manufacturer Labeling and Instructions for Use

Before purchasing, possessing, installing, operating, maintaining, servicing, recommending, advertising, or using a medical device, users must obtain and review the current manufacturer-issued materials applicable to the exact product and jurisdiction, including:

  • Instructions for use
  • Operator manuals
  • Product labeling
  • Intended purpose and indications
  • Warnings
  • Contraindications
  • Precautions
  • Patient-selection criteria
  • Maintenance and calibration requirements
  • Cleaning and infection-control requirements
  • Operator-training requirements
  • Technical specifications
  • Software and firmware requirements
  • Adverse-event and incident-reporting instructions

Wasabi Method content does not replace manufacturer documentation or device-specific training. Where Wasabi Method content differs from current manufacturer labeling or applicable law, users must follow the legally controlling requirement.

9. No Substitution for Regulatory Databases

Wasabi Method content should not be relied upon as evidence that a product is currently authorized, cleared, approved, licensed, included, registered, listed, or otherwise permitted for commercial supply or clinical use.

Users should independently verify product status through official regulatory sources, which may include:

Health Canada’s Medical Devices Active Licence Listing contains product-specific information concerning active licences for Class II, III, and IV medical devices. A Medical Device Establishment Licence relates to specified establishment activities and does not, by itself, constitute approval of each specific device imported or distributed by the licence holder.

Database entries may require careful interpretation. Users should confirm the manufacturer, licence or submission holder, model, device identifier, indication, status, decision date, and jurisdiction before drawing conclusions.

10. Product Names, Trademarks, and Manufacturer References

All device names, manufacturer names, distributor names, product names, service marks, logos, photographs, trade dress, and trademarks referenced by Wasabi Method belong to their respective owners.

Their inclusion is for identification, comparison, commentary, research, news reporting, directory, or educational discussion. Unless expressly disclosed in writing, such inclusion does not imply:

  • Sponsorship
  • Partnership
  • Endorsement
  • Regulatory authorization
  • Commercial affiliation
  • Certification by Wasabi Method
  • Approval of Wasabi Method by the referenced company
  • Approval of the referenced company or product by Wasabi Method

Wasabi Method does not claim ownership of third-party trademarks and does not grant users any right to reproduce, modify, or commercially use third-party intellectual property.

11. Device Neutrality and Commercial Independence

Wasabi Method is intended to provide device-neutral, evidence-informed professional education. Educational content may compare or discuss devices from multiple manufacturers and technology categories.

Manufacturers, distributors, sponsors, exhibitors, faculty members, commercial partners, or other organizations may support particular programs, provide equipment, fund activities, purchase advertising, or participate in Wasabi Method events.

Any such relationship:

  • Does not alter the regulatory status of a device
  • Does not constitute regulatory authorization
  • Does not establish superiority over competing products
  • Does not guarantee inclusion in future educational programs
  • Does not require Wasabi Method to adopt a sponsor’s claims or conclusions

Additional information is available in the Device Neutrality Statement and any applicable conflict-of-interest disclosure.

12. Research Evidence Versus Regulatory Authorization

Scientific evidence and regulatory authorization are separate concepts.

Publication, presentation, recommendation, or discussion of a product or application in any of the following does not independently establish regulatory authorization:

  • A peer-reviewed journal
  • A conference presentation
  • A clinical guideline
  • A professional consensus statement
  • A systematic review or meta-analysis
  • A case report or case series
  • An institutional protocol
  • A research study
  • A Wasabi Method course, article, webinar, or event

Evidence suggesting clinical benefit does not, by itself, establish:

  • FDA clearance, approval, or authorization
  • Inclusion in the Australian Register of Therapeutic Goods
  • A Health Canada medical-device licence
  • UK registration or applicable conformity
  • EU MDR conformity or lawful CE marking
  • Authorization for a particular indication
  • Lawful advertising or reimbursement eligibility

Conversely, regulatory authorization does not guarantee that a product is appropriate for every patient, clinician, facility, condition, or clinical objective.

13. Clinical Protocols and Treatment Parameters

Protocols, energy settings, pressure levels, frequencies, pulse counts, treatment intervals, anatomical applications, patient positions, treatment sequences, and procedural examples presented by Wasabi Method are educational examples only.

They may not be suitable for every:

  • Medical device or device category
  • Model, accessory, or applicator
  • Software or firmware version
  • Patient
  • Diagnosis or condition
  • Profession or practitioner
  • Clinical facility
  • Jurisdiction
  • Regulatory indication

Users must reconcile all educational protocols with the exact device labeling, manufacturer instructions, authorized indications, patient-specific circumstances, facility policies, applicable professional standards, and controlling law.

Wasabi Method does not guarantee that any protocol will produce a particular clinical or commercial outcome.

14. Professional Responsibility and Scope of Practice

Each user is solely responsible for determining whether the user is legally, professionally, and institutionally permitted to:

  • Purchase, import, possess, install, or lease a device
  • Operate or supervise operation of the device
  • Delegate any aspect of its use
  • Evaluate, diagnose, or treat a condition
  • Select patients and screen contraindications
  • Obtain informed consent
  • Advertise or promote a service
  • Bill, code, or seek reimbursement
  • Maintain required clinical and device records
  • Report adverse events or device incidents

Professional scope varies by profession, jurisdiction, licence, certification, training, competence, employer, facility, insurer, and practice setting.

Participation in Wasabi Method education does not expand a user’s lawful scope of practice. See the Scope of Practice Disclaimer.

15. Training and Certification Limitations

Completing a Wasabi Method course, examination, assessment, certificate program, or certification does not:

  • Grant a professional licence
  • Create a government-recognized healthcare credential
  • Expand a clinician’s statutory scope of practice
  • Authorize use of a particular medical device
  • Replace manufacturer-required training
  • Guarantee regulatory compliance
  • Establish competence for every procedure
  • Create hospital, clinic, or facility privileges
  • Authorize independent practice
  • Establish payer enrollment or reimbursement eligibility
  • Prevent disciplinary, employment, insurance, or credentialing action

Users remain responsible for obtaining all licences, registrations, certifications, permits, training, supervision, facility privileges, professional liability coverage, and continuing education required by applicable authorities and organizations.

16. Advertising and Promotional Claims

Users are responsible for ensuring that all advertising and promotional claims comply with applicable medical-device, healthcare-professional, consumer-protection, competition, privacy, and unfair-trade-practice laws.

Wasabi Method content must not be interpreted as:

  • Preapproved advertising language
  • Authorization to promote an off-label or unapproved use
  • Permission to claim guaranteed results
  • Proof that a treatment is safe or effective for every patient
  • Evidence that a product is superior to competing products
  • Authorization to use regulatory logos or terminology
  • Substantiation for a clinical or commercial claim

Users must independently substantiate statements concerning safety, effectiveness, indications, comparative performance, patient outcomes, regulatory status, professional qualifications, and reimbursement.

Advertising should be truthful, accurate, supportable, and not misleading. Educational wording presented by Wasabi Method should not be copied into advertising without an independent compliance review.

17. Investigational Devices and Emerging Technologies

Wasabi Method may discuss investigational, experimental, prototype, prerelease, research-use-only, emerging, modified, or not-yet-authorized devices and technologies.

Discussion of such a product does not mean that it may lawfully be:

  • Commercially supplied
  • Imported or distributed
  • Advertised or promoted
  • Used in routine clinical practice
  • Used outside an authorized investigation
  • Used without institutional, ethical, or regulatory review

Investigational use may be subject to specific regulatory, ethics-review, informed-consent, monitoring, reporting, importation, labeling, and recordkeeping requirements.

18. Geographic Availability

Products, courses, events, memberships, certifications, demonstrations, directory services, and device-related services shown on Wasabi Method websites may not be available in every country, state, province, territory, or locality.

Website availability, online ordering capability, event display, directory inclusion, shipping availability, or access to educational content should not be interpreted as proof that a product or service:

  • Has lawful market authorization
  • May be imported or supplied
  • May be used clinically
  • Falls within the purchaser’s scope of practice
  • May be advertised to patients
  • Is eligible for reimbursement

International users and users accessing the site from foreign jurisdictions are solely responsible for ensuring that their access, use, purchases, importation, possession, distribution, advertising, and clinical activities comply with all applicable local laws.

Wasabi Method may restrict, suspend, cancel, or refuse access, orders, fulfilment, services, or transactions where legal, regulatory, sanctions, export-control, shipping, fraud-prevention, or commercial concerns arise.

19. Regulatory Information May Change

Medical-device laws, regulations, classifications, clearances, approvals, authorizations, registrations, licences, conformity assessments, database entries, labeling, guidance documents, transition periods, enforcement priorities, and agency interpretations may change over time.

Wasabi Method does not guarantee that every regulatory reference remains current after its publication date.

Users should verify regulatory information directly with:

  • The relevant government authority
  • The manufacturer or authorized representative
  • The licence, registration, or submission holder
  • A qualified regulatory professional
  • Applicable official regulatory databases

The absence of an immediate correction or update does not mean that previously published content remains current or applicable.

20. Errors and Corrections

Please report suspected regulatory inaccuracies to info@wasabimethod.com. Wasabi Method may review and correct content but does not guarantee immediate revision.

When reporting a potential error, please provide:

  • The page title and website address
  • The specific statement believed to be inaccurate
  • The relevant product and manufacturer
  • The applicable jurisdiction
  • A link or citation to an official source
  • Your contact information for follow-up, where appropriate

Wasabi Method may revise, clarify, archive, or remove content at its discretion.

21. No Warranty Regarding Regulatory Compliance

To the fullest extent permitted by applicable law, Wasabi Method provides its regulatory and educational content on an “as is” and “as available” basis.

Wasabi Method does not represent or warrant that content is:

  • Complete
  • Current
  • Error-free
  • Accurate for every jurisdiction
  • Applicable to every device, model, or configuration
  • Suitable for a regulatory submission
  • Sufficient to establish compliance
  • Appropriate for a specific factual situation
  • Accepted by a regulator, notified body, licensing board, insurer, employer, or payer
  • Suitable for a particular patient or clinical setting

No statement by Wasabi Method should be treated as a formal regulatory determination or assurance of compliance.

22. Limitation of Liability

To the fullest extent permitted by applicable law, Wasabi Method, its members, managers, officers, employees, contractors, faculty, contributors, agents, affiliates, sponsors, and service providers shall not be responsible for losses, damages, penalties, costs, claims, delays, denials, or liabilities arising from reliance upon website or educational content for:

  • Device purchasing, leasing, financing, or procurement
  • Clinical use or patient treatment
  • Product registration or market access
  • Advertising or promotional claims
  • Importation, exportation, or customs clearance
  • Distribution, resale, or commercial supply
  • Reimbursement, coding, billing, or payer decisions
  • Regulatory submissions or inspections
  • Facility compliance or credentialing
  • Professional licensing or disciplinary matters
  • Adverse events, recalls, or field-safety actions
  • Business, investment, or compliance decisions

This limitation includes direct, indirect, incidental, consequential, special, exemplary, and punitive damages, including loss of revenue, business opportunity, data, reputation, professional standing, reimbursement, or anticipated savings, where such limitations are permitted by law.

Nothing in this Disclaimer excludes or limits liability that cannot lawfully be excluded or limited. Additional limitations and dispute provisions may be stated in the Terms of Use.

23. Seek Qualified Advice

Manufacturers, distributors, importers, clinic owners, healthcare professionals, researchers, educators, investors, and other users should obtain advice appropriate to their jurisdiction and circumstances.

Depending on the issue, qualified sources may include:

  • Medical-device regulatory counsel
  • Qualified medical-device regulatory consultants
  • Professional licensing boards
  • Institutional compliance officers
  • Hospital or facility credentialing departments
  • Medical directors
  • Professional liability insurers
  • Reimbursement and coding specialists
  • Customs and international-trade counsel
  • Relevant government authorities

Users should not delay seeking qualified advice because of information presented by Wasabi Method.

24. Related Legal Notices

This Regulatory Disclaimer should be read together with the following Wasabi Method legal notices:

If a related policy conflicts with this Regulatory Disclaimer, the provision most specifically applicable to the issue should govern, subject to mandatory law and the controlling contractual terms.

25. Contact Information

Questions concerning this Regulatory Disclaimer, suspected regulatory inaccuracies, or regulatory-content concerns may be submitted to Wasabi Method’s compliance contact.

Wasabi Method, LLC
CEO: Adam Gavine, BHK, M.Chiro
CTO & Compliance Officer: Ryan Hansmeyer

Email:
info@wasabimethod.com

United States Office

11500 South Eastern Avenue, Suite 150
Henderson, NV 89052
United States
Tel: +1 253-372-8869

Australia Office

14B Palmers Lane
Bensville, NSW 2251
Australia
Tel: +61 431 227 238

Related Websites

Copyright and Intellectual Property

© 2026 Wasabi Method, LLC. All rights reserved.

All original website content, educational materials, course materials, protocols, research summaries, graphics, videos, recordings, presentations, databases, compilations, branding, logos, and other materials created or owned by Wasabi Method are protected by applicable copyright, trademark, database-right, contract, and other intellectual property laws.

Except where expressly permitted in writing, no Wasabi Method material may be copied, reproduced, republished, uploaded, posted, transmitted, modified, translated, distributed, sold, licensed, used to train an artificial intelligence system, or commercially exploited.

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