# K112348: RS-4I Muscle Stimulator

- Pathway: 510(k) (Special)
- Applicant: Rs Medical
- Decided: Jan 19, 2012 after 156 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000114 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K221958: Flex-MI (2022), 0 descendants of its own

## Indications for use
Interferential Stimulation Indications: Relieve acute pain Relieve and manage chronic pain Muscle Stimulation Indications: Relax muscle spasm Prevention or retardation of 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

Source page: https://510kreport.com/device/K112348
Methodology: https://510kreport.com/methodology