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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Non-Measuring
510(k) Number K120783
Device Name ABLE-X
Applicant
Im-Able, Ltd.
2400 Via Carillo
Palos Verdes Estates,  CA  90274
Applicant Contact SIGI CARON
Correspondent
Im-Able, Ltd.
2400 Via Carillo
Palos Verdes Estates,  CA  90274
Correspondent Contact SIGI CARON
Regulation Number890.5370
Classification Product Code
ION  
Date Received03/15/2012
Decision Date 06/20/2012
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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