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510(k) K170205

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 by Shenzhen Kentro Medical Electronics Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2017
Date Received
January 23, 2017
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.

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  • 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)
  • K200177 — Low-frequency Multi-function physiotherapy instrument (March 25, 2021)
  • 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)

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