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510(k) K092448

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 by Hivox Biotek, Inc. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2010
Date Received
August 10, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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)
  • 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)
  • 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)

Other clearances for product code GZJ

  • K252767 — actiTENS mini (January 16, 2026)
  • K252236 — CP Relief Wand Rx - TENS/NMES (August 15, 2025)
  • K232441 — Unipro (K-UNIPRO-US) (August 30, 2024)
  • K241228 — TENSWave (August 27, 2024)
  • K233046 — Electrical Neuromuscular Stimulator, Cure Trio (April 19, 2024)
  • K222879 — Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) (January 24, 2023)
  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
  • K213802 — StimOnTM Pain Relief System (GM2439) (August 26, 2022)
  • K220578 — Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (May 25, 2022)
  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)