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510(k) K242704

Synchrony (20-3000) by Synapse Biomedical, Inc. — Product Code GZI

K242704 is an FDA 510(k) premarket notification submitted by Synapse Biomedical, Inc. for the device "Synchrony (20-3000)". The FDA issued a decision of Substantially Equivalent on June 5, 2025. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 2025
Date Received
September 9, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

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  • K233006 — MyndMove, MyndMove 2.0 (June 25, 2024)
  • K230997 — EvoWalk 1.0 System (December 28, 2023)
  • K221823 — Cionic Neural Sleeve NS-100 (July 21, 2022)
  • K213925 — MyoCycle MC-2 (Home / Home + / Pro / Pro +) (April 25, 2022)
  • K212149 — MyndMove 2.0 (March 3, 2022)
  • K213622 — Cionic Neural Sleeve NS-100 (February 14, 2022)
  • K202110 — MStim Drop Model: LGT-233 (November 5, 2021)
  • K193276 — Nerve and Muscle Stimulator (September 23, 2020)

FDA data resources