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510(k) K221384

Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 by Hivox Biotek, Inc. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2022
Date Received
May 13, 2022
Clearance Type
Special
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.

  • K242815 — POCKET TENS (EP-300) (December 17, 2024)
  • K232675 — Heating Tens, FT-615 (October 5, 2023)
  • K223308 — HEATING TENS/EMS, FT-810R (May 13, 2023)
  • K211403 — HIVOX OTC Electrical Stimulator, FT610-B (October 15, 2021)
  • K203574 — HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (March 10, 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

  • 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)