# K062325: RS-4I Muscle Stimulator Family

- Pathway: 510(k) (Traditional)
- Applicant: Rs Medical
- Decided: Apr 13, 2007 after 247 days
- Product code: NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K971437 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032652: RS-4I Muscle Stimulator Family, Rs Medical (2003) Summary page 1.
- K971437: Bionicare Stimulator System. Model Bio-1000, Murray Electronics (1997) Summary page 1.
- K030332: Modification to Bionicare Stimulator System, Model Bio-1000, Bionicare Medical Technologies, Inc. (2003) Summary page 1.
- K060669: Medrelief ST Series, Models RT-50, ST-100, ST 150, ST-200, ST-300, Healthonics, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Indications for use
The RS-4i Sequential Stimulator is indicated for use as adjunctive therapy in reducing the level of pain associated with osteoarthritis of the knee.

Source page: https://510kreport.com/device/K062325
Methodology: https://510kreport.com/methodology