# K242704: Synchrony (20-3000)

- Pathway: 510(k) (Traditional)
- Applicant: Synapse Biomedical, Inc.
- Decided: Jun 5, 2025 after 269 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 5.
- K960457: Electronic Muscle Stimulator Model Ems-1C/Ems-2C, Med Labs, Inc. (1996) Summary page 5.

## Indications for use
The Synchrony (20-3000) 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 C5 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES). • Maintenance and/or increase of hand range of motion. • Prevention and/or retardation of disuse atrophy. • Increase in local blood circulation. • Reduction of muscle spasm. • Re-education of muscles.

Source page: https://510kreport.com/device/K242704
Methodology: https://510kreport.com/methodology