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510(k) K200177

Low-frequency Multi-function physiotherapy instrument by Shenzhen Kentro Medical Electronics Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2021
Date Received
January 24, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Shenzhen Kentro Medical Electronics Co., Ltd.

  • K242332 — Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2 (November 5, 2024)
  • K232517 — Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR (December 8, 2023)
  • K222870 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, (May 10, 2023)
  • K220998 — Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (August 24, 2022)
  • K200237 — Transcutaneous Electronic Nerve Stimulator (October 19, 2020)
  • K191982 — Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220 (September 25, 2020)
  • K183288 — Transcutaneous Electrical Nerve Stimulator (July 30, 2019)
  • K181728 — Muscle Trainer (October 17, 2018)
  • K170205 — Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 (May 11, 2017)

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