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510(k) K120569

GEMORE TENS SYSTEM by Gemore Technology Co, Ltd. — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2012
Date Received
February 27, 2012
Clearance Type
Abbreviated
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)
  • 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)
  • K042559 — GEM-TWIN TENS/ MODELS GM3XY/Z (November 17, 2004)

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)