# K200088: g.Estim FES

- Pathway: 510(k) (Traditional)
- Applicant: G.Tec Medical Engineering GmbH
- Decided: Oct 29, 2020 after 288 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: 7 generations back to K930530 (1995). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031017: Sys*Stim 208 and 208A, Mettler Electronics Corp. (2003) Summary page 4.
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 4.

## Indications for use
Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As powered muscle stimulator: • Temporary Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood flow in the treatment area • Muscle re-education • Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles • Maintaining or increasing range of motion As external functional neuromuscular stimulator: • Helps to relearn voluntary motor functions of the extremities The device must be used by trained and qualified personnel.

Source page: https://510kreport.com/device/K200088
Methodology: https://510kreport.com/methodology