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510(k) K163393

Hi-Dow Wireless TENS/EMS System (Model HD-5N) by Hi-Dow International, Inc. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2017
Date Received
December 2, 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 Hi-Dow International, Inc.

  • K233461 — Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) (January 19, 2024)
  • K210383 — Wrap Accessory Electrodes (November 12, 2021)
  • K202337 — Pulsed electromagnetic field wrap (December 15, 2020)
  • K190617 — Wrap accessory electrodes (July 2, 2019)
  • K102598 — HI-DOW-XP (May 13, 2011)

Other clearances for product code NUH

  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • 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)