# K211094: Nerve and Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xft Medical Limited
- Decided: Jul 8, 2021 after 87 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: 3 generations back to K880235 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053266: Myotrac Infiniti, Thought Technology, Ltd. (2005) Summary page 5.

## Indications for use
sEMG: Biofeedback, Relaxation & Muscle Re-Education purposes; NMES (muscle stimulation) and SEMG triggered stimulation (IncludingETS, PAS and MIRROR Mode): 1) Relaxation of muscle spasms; 2) Prevention or retardation of disuse atrophy; 3) Increasing local blood circulation; 4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; 5) Maintaining or increasing range of motion; 6) Stroke Rehab by Muscle re-education.

Source page: https://510kreport.com/device/K211094
Methodology: https://510kreport.com/methodology