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510(k) K060222

LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP by Gemore Technology Co, Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
January 30, 2006
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.

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

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