Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ReWalk(TM)

K-Number: K160987 · 2016-07-22

ApplicantRewalk Robotics, Inc.
Decision Date2016-07-22
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ReWalk(TM) is a medical device manufactured by Rewalk Robotics, Inc.. It received FDA 510(k) clearance on 2016-07-22 under approval number K160987. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReWalk(TM)?

ReWalk(TM) is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Rewalk Robotics, Inc.. The 510(k) number is K160987.

When was ReWalk(TM) approved by the FDA?

ReWalk(TM) received FDA 510(k) clearance on 2016-07-22, under approval number K160987.

What company makes ReWalk(TM)?

ReWalk(TM) is manufactured by Rewalk Robotics, Inc..

What is the FDA product code for ReWalk(TM)?

The FDA product code for ReWalk(TM) is PHL.

Related Devices (Code: PHL)

K161443Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K143690Ekso™ (version 1.1) and Ekso GT™ (version 1.2)Ekso Bionics, Inc. K152416IndegoParker Hannifin Corporation K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. K171334IndegoParker Hannifin Corporation K181294Honda Walking Assist DeviceHonda Motor Company, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑