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510(k) K243828

CIONIC NEURAL SLEEVE (NS-200) by Cionic, Inc. — Product Code GZI

K243828 is an FDA 510(k) premarket notification submitted by Cionic, Inc. for the device "CIONIC NEURAL SLEEVE (NS-200)". The FDA issued a decision of Substantially Equivalent on May 2, 2025. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Cionic, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
December 13, 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

Other clearances by Cionic, Inc.

  • K221823 — Cionic Neural Sleeve NS-100 (July 21, 2022)
  • K213622 — Cionic Neural Sleeve NS-100 (February 14, 2022)

Other clearances for product code GZI

  • K242704 — Synchrony (20-3000) (June 5, 2025)
  • K240632 — Neuvotion NeuStim NN-01 (November 22, 2024)
  • 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