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510(k) K190988

GIM-STIM OTC TENS/EMS System by Gemore Technology Co, Ltd. — Product Code NUH

K190988 is an FDA 510(k) premarket notification submitted by Gemore Technology Co, Ltd. for the device "GIM-STIM OTC TENS/EMS System". The FDA issued a decision of Substantially Equivalent on August 16, 2019. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), 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
August 16, 2019
Date Received
April 15, 2019
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 Gemore Technology Co, Ltd.

  • 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)
  • K042559 — GEM-TWIN TENS/ MODELS GM3XY/Z (November 17, 2004)

Other clearances for product code NUH

  • K261131 — Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-3 (September 6, 2026)
  • K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H) (June 26, 2026)
  • K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (June 16, 2026)
  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (December 31, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K251958 — VEINOPLUS Back (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)

FDA data resources