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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name powered exoskeleton
De Novo Number DEN130034
510(K) Number K131798
Device Name REWALK
33 locke dr.
suite 240
marlborough,  MA  01752
Contact john v hamilton
Regulation Number890.3480
Classification Product Code
Date Received06/17/2013
Decision Date 06/26/2014
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct