# K170564: MyndMove System, MyndMove Functional Electrical Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Myndtec, Inc.
- Decided: Aug 30, 2017 after 184 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.
2 later devices descend from it; 2 cite it directly.
0 of 5 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 4.

## Most influential descendants
- K212149: MyndMove 2.0 (2022), 1 descendant of its own
- K233006: MyndMove, MyndMove 2.0 (2024), 0 descendants of its own

## Indications for use
MYNDMOVE is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) o Improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3 - T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) o Maintenance and/or increase of arm and 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. MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove System.

Source page: https://510kreport.com/device/K170564
Methodology: https://510kreport.com/methodology