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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning
510(k) Number K091833
Device Name GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.
Applicant
Gemore Technology Co, Ltd.
11 Floor , #29-5, Sec.2, Chung Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Applicant Contact BODEN LAI
Correspondent
Gemore Technology Co, Ltd.
11 Floor , #29-5, Sec.2, Chung Cheng E. Rd.,
Tan Shui, New Taipei City,  TW 251
Correspondent Contact BODEN LAI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received06/22/2009
Decision Date 10/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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