# K123636: H200 Wireless Hand Rehabilitation System with Optional Intelli-Connect Earpiece Triggering Device

- Pathway: 510(k) (Traditional)
- Applicant: Bioness, Inc.
- Decided: May 1, 2013 after 159 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: 1 generation back to K111767 (2011). 1 ancestor in all.
5 later devices descend from it; 3 cite 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)
- K111767: Ness H200 Wireless Hand Rehabilitation System User Kit and Clinican Kit, Ness-Neuromuscular Electrical Stimulation Systems (2011) Summary page 1.

## Most influential descendants
- 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
- K233006: MyndMove, MyndMove 2.0 (2024), 0 descendants of its own

## Indications for use
The [NESS] H200 Wireless System is an electrical stimulation device indicated for the following uses: *Functional Electrical Stimulation (FES). o Improvement of hand function and active range of motion in patients with hemniplegia due to stroke or upper limb paralysis due to C5 spinal cord injury. * NeuroMuscular Electrical Stimulation (NMES). o Maintenance and/or increase of hand range of motion. o Prevention and/or retardation of disuse atrophy. o Increase in local blood circulation. o Reduction of muscle spasm. o Re-education of muscles. The Intelli-Connect is an optional accessory device used exclusively with the H200 Wireless Orthosis through simple jaw movements.

Source page: https://510kreport.com/device/K123636
Methodology: https://510kreport.com/methodology