# K972093: Regenesis Model 42

- Pathway: 510(k) (Traditional)
- Applicant: Regenesis Biomedical, Inc.
- Decided: Oct 21, 1997 after 139 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903675 (1991). 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)
- K903675: Magnetic Resonance Therapy Device, Mrt, Inc. (1991) Summary page 5.

## Recalls of this device
- Sep 29, 2008 · Not classified · Z-0887-2009: In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As 

## Indications for use
The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Source page: https://510kreport.com/device/K972093
Methodology: https://510kreport.com/methodology