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510(k) K162517

Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 by Jkh Health Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2017
Date Received
September 9, 2016
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 Jkh Health Co., Ltd.

  • K253150 — Cryon-X Cold Compression (October 24, 2025)
  • K240788 — Ultrasound Stimulator (June 4, 2025)
  • K240986 — Cold Compression (May 1, 2024)
  • K240011 — Lymphedema Compression (February 23, 2024)
  • K223541 — Cold/Hot Compression (October 27, 2023)
  • K211050 — Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 (November 28, 2022)
  • K202839 — Overlapped Compression Therapy (January 21, 2021)
  • K200561 — StimPlus Patch, StimPlus Patch, StimPlus Patch (July 1, 2020)
  • K153520 — Electronic Pulse Stimulator (May 5, 2016)

Other clearances for product code NUH

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  • K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (December 31, 2025)
  • K251958 — VEINOPLUS Back (December 23, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • 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)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)