# K111767: Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit

- Pathway: 510(k) (Traditional)
- Applicant: Ness-Neuromuscular Electrical Stimulation Systems
- Decided: Sep 15, 2011 after 84 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices 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.

## Most influential descendants
- K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device (2013), 5 descendants of its own
- K170564: MyndMove System, MyndMove Functional Electrical Stimulator (2017), 2 descendants of its own
- K212149: MyndMove 2.0 (2022), 1 descendant of its own
- K242704: Synchrony (20-3000) (2025), 0 descendants of its own
- K240632: Neuvotion NeuStim NN-01 (2024), 0 descendants of its own

## Indications for use
The NESS H200®D Wireless Hand Rehabilitation System 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 05 spinal cord injury NeuroMuscular Electrical Stimulation (NMES): - Maintenance and/or increase of range of motion - Prevention and/or retardation of disuse atrophy - Increase of local blood circulation - Reduction of muscle spasm - Muscle re-education

Source page: https://510kreport.com/device/K111767
Methodology: https://510kreport.com/methodology