# K171071: StimSox (TM) System

- Pathway: 510(k) (Traditional)
- Applicant: Stimmed, LLC
- Decided: Aug 9, 2017 after 121 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: 4 generations back to K932299 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123354: Revitive IX, Actegy, Ltd. (2013) Summary page 4.
- K151922: StimSox (TM) System, Stimmed, LLC (2016) Summary page 5.

## Indications for use
The StimSox™ System is indicated to temporarily increase local blood circulation in healthy leg muscles and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K171071
Methodology: https://510kreport.com/methodology