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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
Original Applicant
LETO ENTERPRISES INCORPORATION
suite a-2706, zhongfang jingyuan
xinwen road, futian district
shenzhen,  CH 518100
Original Contact sabrina wei
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/08/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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