Home / 510(k) Clearances / K062675

510(k) K062675

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES by Gemore Technology Co, Ltd. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2007
Date Received
September 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
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)
  • 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 GXY

  • K260453 — Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60) (March 12, 2026)
  • K254033 — Ceribell Instant EEG Headset (February 9, 2026)
  • K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (October 31, 2025)
  • K250841 — Electrotherapy Electrodes (August 13, 2025)
  • K243788 — IceCap product line (March 13, 2025)
  • K243243 — Delphi MCS Electrode Cap (February 6, 2025)
  • K241512 — Electrode Pad (January 15, 2025)
  • K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50) (January 2, 2025)
  • K241160 — CAIs Sensor (CAIs-001) (December 13, 2024)
  • K240575 — WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) (November 25, 2024)