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510(k) K233006

MyndMove, MyndMove 2.0 by Myndtec, Inc. — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2024
Date Received
September 22, 2023
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

Other clearances by Myndtec, Inc.

  • K212149 — MyndMove 2.0 (March 3, 2022)
  • K170564 — MyndMove System, MyndMove Functional Electrical Stimulator (August 30, 2017)

Other clearances for product code GZI

  • K242704 — Synchrony (20-3000) (June 5, 2025)
  • K243828 — CIONIC NEURAL SLEEVE (NS-200) (May 2, 2025)
  • K240632 — Neuvotion NeuStim NN-01 (November 22, 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)