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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 K102295
Device Name X2ABS DUAL CHANNEL FITNESS BELT
Applicant
Leto Enterprises Incorporation
19/F, Nan Dao Commercial Bldg,
Queens Rd. Central
Hong Kong,  CN 999077
Applicant Contact SABRINA WEI
Correspondent
Leto Enterprises Incorporation
19/F, Nan Dao Commercial Bldg,
Queens Rd. Central
Hong Kong,  CN 999077
Correspondent Contact SABRINA WEI
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/13/2010
Decision Date 02/18/2011
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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