WEBSITE DISCLAIMER, MEDICAL DEVICE REGULATORY & PRESCRIPTION-ONLY PURCHASE POLICY
Effective Date: 20 October 2026
1. General Information and Website Disclaimer
This website (the “Website”) is owned and operated by General Vibronics, Inc. (“General Vibronics,” “Company,” “we,” “us,” or “our”).
All information, materials, and content made available through this Website, including, without limitation, product descriptions, technical specifications, clinical research, educational materials, illustrations, videos, treatment-related information, and other communications (collectively, the “Content”), are provided solely for general informational, educational, and professional reference purposes.
The Content does not constitute medical advice, diagnosis, treatment recommendations, or the establishment of a physician-patient or other healthcare professional-patient relationship.
General Vibronics makes reasonable efforts to maintain accurate and current information. However, except as expressly required by applicable law, the Company makes no representation or warranty that all Website Content is complete, accurate, current, or suitable for any medical or clinical purpose.
2. Prescription-Only Medical Device – Restricted Sales and Distribution
IMPORTANT REGULATORY NOTICE – Rx Only
The MIRARI® Cold Plasma System is a U.S. Food and Drug Administration (FDA)-cleared Class II medical device subject to applicable federal and state medical device regulations, including prescription-device restrictions under Title 21 of the Code of Federal Regulations, Section 801.109, as applicable.
MIRARI® products designated as prescription medical devices are not available for unrestricted consumer purchase.
In accordance with applicable federal and state laws:
- Authorized Purchasers: Orders and purchases are restricted to healthcare practitioners licensed by applicable state law to use or order the device, and to healthcare facilities, distributors, or other entities legally authorized to acquire the device pursuant to a valid order from such practitioners, as applicable.
- Prescription Requirement: The device may be sold only by or on the order of a practitioner licensed by law to use or order the device, consistent with applicable prescription-device requirements.
- Professional Use: The device must be used in accordance with its FDA-cleared indications, approved operating instructions, applicable labeling, and relevant professional licensing requirements.
- Purchaser Verification: General Vibronics reserves the right to verify professional licensure, organizational credentials, purchasing authority, and other documentation reasonably necessary to establish compliance with applicable laws.
- Order Acceptance: Submission of an online inquiry, purchase request, quotation request, or order does not constitute acceptance of an order or authorization to purchase a prescription medical device. All orders are subject to verification, approval, and acceptance by General Vibronics.
General Vibronics reserves the right to reject, suspend, or cancel any transaction that does not satisfy applicable regulatory, professional licensing, or Company compliance requirements.
Nothing contained on this Website constitutes an offer to sell prescription medical devices to persons or entities not legally authorized to purchase or receive them.
3. Medical Device Regulatory Status and Intended Use
The MIRARI® Cold Plasma System is an FDA-cleared Class II medical device incorporating radiofrequency (RF) technology.
The device is intended for use only within the indications, conditions, operating parameters, and limitations specified in its applicable FDA-cleared labeling.
General Vibronics does not represent that the device has been cleared or approved by the FDA for any indication, clinical application, or therapeutic benefit beyond those expressly authorized under applicable regulatory requirements.
References to clinical research, scientific publications, investigational applications, or emerging technologies are provided for educational purposes and should not be interpreted as authorization for unapproved or uncleared medical uses.
FDA clearance does not constitute FDA endorsement or a guarantee of clinical effectiveness for every patient or medical condition.
Healthcare professionals are responsible for determining the clinical appropriateness of device use within applicable regulatory requirements and their professional scope of practice.
4. Professional Medical Judgment and Patient Safety
The MIRARI® Cold Plasma System is intended for use by appropriately trained healthcare professionals in accordance with its labeling, operating instructions, and applicable professional requirements.
The information presented on this Website is not intended to replace independent professional medical judgment.
All patient assessments, treatment decisions, device applications, and clinical monitoring must be conducted by or under the appropriate direction of qualified healthcare professionals, as permitted by applicable law and device labeling.
Healthcare professionals are responsible for:
- Evaluating patient eligibility, medical history, and relevant clinical conditions.
- Identifying contraindications, warnings, precautions, and potential treatment risks.
- Determining appropriate treatment protocols within the device’s authorized indications and operating parameters.
- Ensuring adequate training, proper device operation, and patient monitoring.
- Complying with applicable professional standards, institutional policies, and regulatory obligations.
General Vibronics does not practice medicine or direct the independent clinical judgment of licensed healthcare professionals.
5. Not a Substitute for Professional Medical Advice
Information regarding medical conditions, pain management, therapeutic technologies, clinical studies, and treatment-related subjects is provided for general educational purposes.
Individuals seeking medical advice should consult a qualified and appropriately licensed healthcare professional.
Website visitors should not disregard professional medical advice, delay necessary medical evaluation, or initiate treatment based solely on information presented on this Website.
No information published by General Vibronics should be interpreted as a recommendation for self-diagnosis, self-treatment, or unauthorized operation of a prescription medical device.
6. Clinical Outcomes and No Guarantee of Results
The MIRARI® Cold Plasma System utilizes RF energy technology for applications within its FDA-cleared indications, which may include the application of therapeutic heat for temporary relief of pain and muscle spasms and temporary increases in local circulation, to the extent expressly supported by the device’s applicable cleared labeling.
Any clinical performance information, scientific discussion, or research findings presented on this Website must be interpreted in the context of the underlying evidence, study limitations, and authorized device indications.
General Vibronics does not warrant or guarantee any therapeutic outcome, degree of symptom relief, clinical improvement, or treatment response.
Individual outcomes may vary based on factors including patient characteristics, underlying medical conditions, treatment parameters, practitioner judgment, and adherence to applicable instructions for use.
Nothing in this Disclaimer limits any express product warranty separately provided by General Vibronics or any rights or remedies that cannot lawfully be excluded.
7. Product Information, Availability, and Online Transactions
Product descriptions, technical information, pricing, and availability published on this Website are subject to change without notice, except as otherwise required by applicable law or binding contractual commitments.
The display of any product on this Website does not constitute an unconditional offer for sale.
All orders for prescription medical devices are subject to:
- Verification of purchaser eligibility and applicable professional credentials.
- Compliance with federal, state, and local laws governing prescription medical devices.
- Applicable distribution, shipping, and jurisdictional restrictions.
- Acceptance by General Vibronics and any applicable written sales terms.
General Vibronics may request additional documentation before processing or fulfilling an order.
Purchasers are prohibited from misrepresenting their professional qualifications, licensing status, or legal authority to acquire prescription medical devices.
8. Regulatory Compliance and Geographic Restrictions
Medical device classifications, regulatory authorizations, permitted indications, labeling requirements, and distribution restrictions may differ among jurisdictions.
FDA clearance in the United States does not automatically authorize marketing, sale, distribution, or clinical use in other countries.
Products described on this Website may not be available or legally authorized for distribution in every jurisdiction.
All purchasers, distributors, and healthcare professionals must comply with applicable laws and regulatory requirements governing the acquisition, distribution, and use of medical devices in their respective jurisdictions.
General Vibronics reserves the right to restrict sales or distribution where necessary to maintain regulatory compliance.
9. Intellectual Property and Proprietary Technology
Unless otherwise expressly stated, the trademarks, trade names, product names, logos, graphics, technical documentation, Website design elements, and other proprietary materials displayed on this Website are owned by General Vibronics or used under appropriate authorization.
MIRARI® and other identified trademarks are the property of their respective owners.
No Website Content may be reproduced, distributed, modified, commercially exploited, or used to imply endorsement by General Vibronics without prior written authorization, except as otherwise permitted by applicable law.
Nothing on this Website grants any license or other rights in intellectual property by implication, estoppel, or otherwise.
10. Disclaimer of Warranties
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THIS WEBSITE AND ITS CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS, WITHOUT WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF ACCURACY, COMPLETENESS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
This provision applies solely to the Website and its Content and does not supersede any applicable written product warranty, purchase agreement, or mandatory statutory protection.
11. Limitation of Liability
To the maximum extent permitted by applicable law, General Vibronics, Inc., together with its officers, directors, employees, affiliates, representatives, and agents, shall not be liable for indirect, incidental, special, consequential, exemplary, or punitive damages arising from or relating to:
- Access to, use of, or inability to access the Website.
- Reliance upon inaccurate, incomplete, or outdated Website Content.
- Unauthorized interpretation or application of general educational or technical information.
- Website interruptions, errors, or technical malfunctions.
Nothing in this Disclaimer shall exclude or limit liability for personal injury, defective products, gross negligence, willful misconduct, or other matters to the extent such liability cannot lawfully be excluded or limited.
Product sales, warranties, and related contractual liabilities shall be governed by the applicable purchase agreement, product warranty, and mandatory provisions of law.
12. Governing Law and Jurisdiction
Except where prohibited by applicable law, this Disclaimer shall be governed by and construed in accordance with the laws of the State of Arizona, United States, without regard to its conflict-of-laws principles.
Any dispute arising from or relating to this Disclaimer or use of the Website shall be brought before the state or federal courts of competent jurisdiction located in Arizona, subject to applicable law and any enforceable written agreement between the parties.
13. Amendments and Updates
General Vibronics reserves the right to amend, modify, or update this Disclaimer at any time to reflect changes in applicable law, regulatory requirements, Company policies, or Website operations.
Revisions will become effective upon publication on this Website unless otherwise stated or required by applicable law.
14. Contact Information
For questions concerning this Disclaimer, prescription-device purchasing eligibility, regulatory requirements, or product information, please contact:
General Vibronics, Inc.
Email: [email protected]
Website: https://generalvibronics.com
PRESCRIPTION DEVICE NOTICE
Rx Only – Federal law restricts this device to sale by or on the order of a practitioner licensed by law to use or order the device.
All purchases are subject to professional credential verification and applicable regulatory requirements.