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510(k) DEN130034

REWALK by Argo Medical Technologies, Inc. — Product Code PHL

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 26, 2014
Date Received
June 17, 2013
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Exoskeleton
Device Class
Class II
Regulation Number
890.3480
Review Panel
NE
Submission Type

A powered exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened lower extremity limb(s) for medical purposes.

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