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510(k) K191982

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) by Shenzhen Kentro Medical Electronics Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2020
Date Received
July 25, 2019
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)
  • K200177 — Low-frequency Multi-function physiotherapy instrument (March 25, 2021)
  • K200237 — Transcutaneous Electronic Nerve Stimulator (October 19, 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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  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
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