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510(k) K211094

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2021
Date Received
April 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Shenzhen Xft Medical Limited

  • K193276 — Nerve and Muscle Stimulator (September 23, 2020)
  • K193275 — Nerve and Muscle Stimulator (April 11, 2020)
  • K162718 — Foot Drop System (Model XFT-2001D) (November 30, 2017)

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