ViVY Diathermy, Shortwave
510(k) K250376
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250376 | Date5 Nov 2025 | 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- Withdrawn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
- Full name
- ViVY
- 510(k) Number
- FDA Product Code
- IMJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5290
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
ViVY is a shortwave diathermy device designed for applying therapeutic deep heat. Classified as a Class II medical device under FDA regulations, it operates within the physical medicine specialty, delivering controlled electromagnetic energy to promote tissue heating for therapeutic purposes. This modality is commonly used to alleviate chronic pain, reduce muscle spasms, and improve joint mobility by enhancing circulation and tissue repair processes.
The device is supplied as a reusable medical instrument, intended for use in clinical settings such as physical therapy or rehabilitation facilities. It is not sterile and requires proper cleaning and maintenance between uses. ViVY adheres to FDA clearance (K250376) under the 510(k) pathway, with regulatory classification as a diathermy device for deep heat application. No MRI safety information or specific sterility standards are noted in the available data.
Other devices from Viatherm Therapeutics, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the ViVY device used for in clinical settings?
The ViVY is a shortwave diathermy device designed to apply therapeutic deep heat to tissues. It’s primarily used in physical medicine to alleviate chronic pain, reduce muscle spasms, and improve joint mobility by enhancing circulation and promoting tissue repair. This modality is particularly valuable in rehabilitation and physical therapy environments where controlled heating is beneficial.
Is the ViVY device single-use or reusable, and what cleaning requirements apply?
The ViVY is a reusable medical instrument, intended for repeated use in clinical settings. Since it is not sterile, proper cleaning and maintenance between uses are required to ensure safety and functionality. Follow manufacturer guidelines for disinfection to prevent cross-contamination and maintain device performance.
Does the ViVY device come pre-sterilized, and what are its regulatory standards?
The ViVY is not supplied sterile and is not intended for sterile procedures. It is classified as a Class II medical device under FDA regulations and has received FDA clearance (K250376) under the 510(k) pathway for use in applying therapeutic deep heat. The clearance is based on its substantial equivalence to existing devices in the physical medicine category.
Are there different models or sizes available for the ViVY device?
The provided data does not specify multiple models or sizes for the ViVY device. It is described as a single shortwave diathermy unit designed for deep heat therapy. For specific configurations or customization options, refer to the manufacturer’s documentation or contact Viatherm Therapeutics directly.
How should the ViVY device be stored to maintain its performance?
While the data does not detail storage specifications, reusable medical devices like the ViVY generally require protection from physical damage, moisture, and extreme temperatures. Store in a clean, dry environment, away from direct sunlight or sources of electromagnetic interference. Follow the manufacturer’s instructions for long-term storage and maintenance to preserve functionality and safety.