# K131979: Provant Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Regenesis Biomedical, Inc.
- Decided: Dec 13, 2013 after 168 days
- Product code: ILX (Diathermy, Shortwave, For Use Other Than 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 K091791 (2010). 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)
- K091791: Provant System, Model 4201, Regenesis Biomedical, Inc. (2010) Summary page 5.

## Indications for use
The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Source page: https://510kreport.com/device/K131979
Methodology: https://510kreport.com/methodology