Home / 510(k) Clearances / K032994

510(k) K032994

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) by Gemore Technology Co, Ltd. — Product Code GZJ

K032994 is an FDA 510(k) premarket notification submitted by Gemore Technology Co, Ltd. for the device "GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)". The FDA issued a decision of Substantially Equivalent on December 16, 2003. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Gemore Technology Co, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2003
Date Received
September 25, 2003
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 Gemore Technology Co, Ltd.

  • K190988 — GIM-STIM OTC TENS/EMS System (August 16, 2019)
  • K150681 — GEMORE OTC TENS (May 12, 2015)
  • K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (December 21, 2012)
  • K122948 — GEM-STIM COMBO STIMULATOR (December 21, 2012)
  • K120569 — GEMORE TENS SYSTEM (July 20, 2012)
  • K102933 — GEM-TONE BODY TRAINING SYSTEM (September 2, 2011)
  • K102926 — GEMORE MUSCLE CONDITIONER; (August 25, 2011)
  • K091833 — GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350P (October 16, 2009)
  • K062675 — GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DO (January 4, 2007)
  • K060222 — LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP (April 28, 2006)

Other clearances for product code GZJ

  • K252712 — STIMPOD NMS460 Nerve Stimulator (May 28, 2026)
  • 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)

FDA data resources