# K212149: MyndMove 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Myndtec, Inc.
- Decided: Mar 3, 2022 after 237 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: 3 generations back to K111767 (2011). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K170564: MyndMove System, MyndMove Functional Electrical Stimulator, Myndtec, Inc. (2017) Summary page 4.

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

## Indications for use
MYNDMOVE 2.0 is an electrical stimulation device indicated for the following uses: Functional Electrical Stimulation (FES) Improvement of arm and hand functions 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) • Maintenance and/or increase of arm and hand range of motion • Prevention and/or retardation of disuse atrophy • Increase in local blood circulation • Reduction of muscle spasm • Re-education of muscles. MyndMove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove System.

Source page: https://510kreport.com/device/K212149
Methodology: https://510kreport.com/methodology