# K240632: Neuvotion NeuStim NN-01

- Pathway: 510(k) (Traditional)
- Applicant: Neuvotion, Inc.
- Decided: Nov 22, 2024 after 261 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: 2 generations back to K111767 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device, Bioness, Inc. (2013) Summary page 5.

## Indications for use
The NeuStim NN-01 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 due to stroke or upper limb paralysis due to C5 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES): • Maintaining or increasing hand range of motion; • Prevention or retardation of disuse atrophy; • Increasing local blood circulation; • Relaxation of muscle spasms; and • Muscle re-education. The NeuStim NN-01 is intended for use on the right arm/right hand only.

Source page: https://510kreport.com/device/K240632
Methodology: https://510kreport.com/methodology