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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
Original Applicant
2400 via carillo
palos verdes estates,  CA  90274
Original Contact sigi caron
Regulation Number890.5370
Classification Product Code
Date Received03/15/2012
Decision Date 06/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No