# K153163: ReGrasp

- Pathway: 510(k) (Traditional)
- Applicant: Rehabtronics, Inc.
- Decided: Apr 7, 2016 after 157 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ReGrasp is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES): - Improvement of hand-function and active range of motion in patients with hemiplegia or upper limb paralysis due to stroke, traumatic or acquired brain injury, or C5 level cervical spinal cord injury. Neuromuscular Electrical Stimulation (NMES): - Maintenance and/or increase of range of motion - Prevention and/or reduction of disuse atrophy - Increase of local blood circulation - Reduction of muscle spasms - Muscle re-education

Source page: https://510kreport.com/device/K153163
Methodology: https://510kreport.com/methodology