# K250376: ViVY

- Pathway: 510(k) (Traditional)
- Applicant: Viatherm Therapeutics, LLC
- Decided: Nov 5, 2025 after 268 days
- Product code: IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K173300 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173300: ViaTherm BOOST, Viatherm Therapeutics, LLC (2018) Summary page 5.

## Indications for use
The VIVY™ is to be used to generate deep heat within body tissues for the treatment of medical conditions such as relief of pain and muscle spasms.

Source page: https://510kreport.com/device/K250376
Methodology: https://510kreport.com/methodology