# K102202: GS 3000

- Pathway: 510(k) (Traditional)
- Applicant: Emsi
- Decided: Nov 23, 2010 after 111 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 K946299 (1995). 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)
- K946299: PGS123 and HVS-123, Skylark Device Co., Ltd. (1995) Summary page 1.

## Indications for use
Relaxation of muscle spasm Increasing local blood circulation Maintaining or increasing range of motion Preventing or retarding disuse atrophy Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K102202
Methodology: https://510kreport.com/methodology