# K162683: RehaStim 2

- Pathway: 510(k) (Traditional)
- Applicant: Hasomed GmbH
- Decided: Feb 3, 2017 after 130 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K841112 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112844: Rehastim 2, Rehamove 2, Hasomed GmbH (2011) Summary page 5.
- K132416: Rehastim 2, Erigopro (Fes), Hasomed GmbH (2014) Summary page 5.

## Indications for use
The RehaStim 2 stimulator is intended for general rehabilitation 1. Relaxation of muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Maintaining or increasing range of motion The RehaStim 2 is an External Functional Neuromuscular Stimulator, designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.

Source page: https://510kreport.com/device/K162683
Methodology: https://510kreport.com/methodology