ReWalk(TM)— 510(k) K160987

Substantially Equivalent

Rewalk Robotics, Inc.

FDA 510(k) clearance K160987 for ReWalk(TM), Substantially Equivalent on 2016-07-22. Applicant: Rewalk Robotics, Inc..

Clearance details

Applicant: Rewalk Robotics, Inc.
Product code: Code PHL
Advisory panel: Physical Medicine
Date received: 2016-04-08
Decision date: 2016-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Marlborough, MA, US

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