# K955736: STIM-8

- Pathway: 510(k) (Traditional)
- Applicant: Bmr, Ltd.
- Decided: May 22, 1996 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: 1 generation back to K860315 (1986). 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)
- K860315: Neurotech-16 Program System Controller Model 280, Neurotech, Inc. (1986) Summary page 1.

## Indications for use
The Stim-8 is used for stimulation of muscles for the purposes of relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis and maintaining or increasing range of motion.

Source page: https://510kreport.com/device/K955736
Methodology: https://510kreport.com/methodology