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510(k) K193276

Nerve and Muscle Stimulator by Shenzhen Xft Medical Limited — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2020
Date Received
November 26, 2019
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 Shenzhen Xft Medical Limited

  • K211094 — Nerve and Muscle Stimulator (July 8, 2021)
  • K193275 — Nerve and Muscle Stimulator (April 11, 2020)
  • K162718 — Foot Drop System (Model XFT-2001D) (November 30, 2017)

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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)