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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 K122414
Device Name AB COMMAND DUAL CHANNEL FITNESS BELT
Applicant
LETO ENTERPRISES INCORPORATION
SUITE A-2706, ZHONGFANG JINGYUAN
XINWEN ROAD, FUTIAN DISTRICT
SHENZHEN,  CN 518100
Applicant Contact SABRINA WEI
Correspondent
LETO ENTERPRISES INCORPORATION
SUITE A-2706, ZHONGFANG JINGYUAN
XINWEN ROAD, FUTIAN DISTRICT
SHENZHEN,  CN 518100
Correspondent Contact SABRINA WEI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/08/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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