# K241488: TrainFES Advance

- Pathway: 510(k) (Traditional)
- Applicant: Trainfes
- Decided: Feb 5, 2025 after 257 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: 8 generations back to K930530 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210002: Stella Bio, Egzotech Sp. Z O. O. (2021) Summary page 5.

## Indications for use
For Prescription and Home Use by prescription from a medical professional: The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions: Relaxation of muscle spasms Prevention or retardation of disuse atrophy increasing local blood circulation immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Muscle re-education As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions: Helps to relearn voluntary motor functions of the extremities. TrainFES’ Advanced intended population is anybody aged 22 or over. Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home. Platform: TrainFES is a battery-powered, wireless device, accessible through software.

Source page: https://510kreport.com/device/K241488
Methodology: https://510kreport.com/methodology