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510(k) K203574

HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 by Hivox Biotek, Inc. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2021
Date Received
December 7, 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 Hivox Biotek, Inc.

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  • K232675 — Heating Tens, FT-615 (October 5, 2023)
  • K223308 — HEATING TENS/EMS, FT-810R (May 13, 2023)
  • K221384 — Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 (June 11, 2022)
  • K211403 — HIVOX OTC Electrical Stimulator, FT610-B (October 15, 2021)
  • K192264 — HIVOX Spopad EMS SP-911, SP-921 (November 8, 2019)
  • K190347 — HIVOX OTC Electrical Stimulator (March 15, 2019)
  • K171803 — HIVOX OTC Electrical Stimulator (November 29, 2017)
  • K143737 — EM25 - glute toning device (July 27, 2015)
  • K141921 — HIVOX SPOPAD EMS (January 16, 2015)

Other clearances for product code NUH

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  • 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)