Relax-a-Tone
by Bio Response
510(k) K780436
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780436 | Date12 May 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HCC
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Relax-a-Tone is a biofeedback device designed to assist users in learning voluntary control of physiological responses, such as muscle tension or relaxation, through real-time feedback. It is classified as a Class II medical device and falls under the category of biofeedback systems, aiding in the management of neurological conditions by promoting relaxation and stress reduction.
This device is intended for use in clinical and home settings, supplied as a reusable system. It operates without MRI restrictions and is authorized under an FDA 510(k) clearance (K780436) with a decision date of May 12, 1978. No specific sterility or single-use requirements are noted in the regulatory data, and its primary application is within neurology, as referenced in the advisory committee classification.
Questions
AI-generated answers, 20 Sep 2026
What clinical specialties is the Relax-a-Tone primarily used in, and how does it help patients?
The Relax-a-Tone is classified under neurology and is designed to assist users in managing neurological conditions by promoting relaxation and stress reduction. It works as a biofeedback device, providing real-time feedback to help users learn voluntary control of physiological responses like muscle tension. This can be particularly useful for patients dealing with stress-related neurological symptoms or those undergoing therapy for conditions influenced by muscle tension or relaxation.
Is the Relax-a-Tone safe to use in an MRI environment, and how is it supplied?
Yes, the Relax-a-Tone is explicitly noted as operating without MRI restrictions, meaning it can be safely used in environments where MRI scans are conducted. It is supplied as a reusable system, which means it is designed for multiple uses rather than single-use applications, reducing waste and potentially lowering costs for clinical or home settings.
What regulatory pathway was followed for FDA clearance of the Relax-a-Tone, and when was it approved?
The Relax-a-Tone received FDA clearance through a traditional 510(k) pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted on May 12, 1978, under the registration number K780436. This pathway is commonly used for Class II medical devices like biofeedback systems to ensure they meet safety and effectiveness standards.
Are there multiple models or sizes available for the Relax-a-Tone, and how would I identify them?
The Relax-a-Tone appears to be available in multiple configurations, as indicated by the extensive list of registration numbers (e.g., 3039260720, 3015497638, etc.) in the regulatory data. These numbers likely correspond to different models or variations of the device. While exact specifications for each model aren’t detailed here, these identifiers can be used to cross-reference with manufacturer documentation or product catalogs to determine compatibility with specific clinical needs.
How should the Relax-a-Tone be stored, and are there any special handling requirements?
Since the Relax-a-Tone is a reusable biofeedback system and no specific sterility requirements are mentioned in the regulatory data, storage should follow general guidelines for reusable medical devices. This typically includes keeping the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and ensuring it is properly calibrated and maintained according to the manufacturer’s instructions. Always refer to the manufacturer’s guidelines for detailed storage and maintenance protocols.