# K233006: MyndMove, MyndMove 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Myndtec, Inc.
- Decided: Jun 25, 2024 after 277 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: 4 generations back to K111767 (2011). 4 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K212149: MyndMove 2.0, Myndtec, Inc. (2022) Summary page 5.

## Indications for use
MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses: Functional electrical stimulation (FES) 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) for general rehabilitation for: • maintenance and/or increase of arm and hand range of motion, • prevention and/or retardation of disuse atrophy, • increase in local blood circulation, • reduction in muscle spasm, and • re-education of muscles. MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove and MyndMove 2.0 Systems.

Source page: https://510kreport.com/device/K233006
Methodology: https://510kreport.com/methodology