# K071093: San Shih Powered Muscle Stimulator, Model 202

- Pathway: 510(k) (Traditional)
- Applicant: San Shih Electrical Enterprise Co., Ltd.
- Decided: Dec 6, 2007 after 232 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 K023000 (2003). 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)
- K023000: Home Care Various Models of Powered Muscle Stimulator, HT-329M Series, Home Care Technology Co., Ltd. (2003) Summary page 1.

## Indications for use
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as: * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis * Maintaining or increasing range of motion Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Source page: https://510kreport.com/device/K071093
Methodology: https://510kreport.com/methodology