# K091791: Provant System, Model 4201

- Pathway: 510(k) (Traditional)
- Applicant: Regenesis Biomedical, Inc.
- Decided: Apr 7, 2010 after 294 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Regenesis Model 42: named in the summary without a submission number

## Most influential descendants
- K131979: Provant Therapy System (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K091791
Methodology: https://510kreport.com/methodology