# K032652: RS-4I Muscle Stimulator Family

- Pathway: 510(k) (Traditional)
- Applicant: Rs Medical
- Decided: Sep 12, 2003 after 15 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K000114 (2000). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000114: RS-4M+Muscle Stimulator, Rs Medical (2000)

## Most influential descendants
- K112348: RS-4I Muscle Stimulator (2012), 1 descendant of its own
- K221958: Flex-MI (2022), 0 descendants of its own
- K062325: RS-4I Muscle Stimulator Family (2007), 0 descendants of its own
- K034005: SDS-4I (2004), 0 descendants of its own

## Recalls of this device
- Jun 11, 2008 · Not classified · Z-0323-2011: The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery 

## Indications for use
Muscle Stimulation, Interferential and Non-Interferential Modality Relax muscle spasms Prevent or retard disuse atrophy Maintain or increase range of motion Increase local blood circulation Re-educate muscle Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Pain Relief, Interferential Current Modality Relieve acute pain Relieve and manage chronic pain

Source page: https://510kreport.com/device/K032652
Methodology: https://510kreport.com/methodology