510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160987Substantially Equivalent

ReWalk(TM)

Rewalk Robotics, Inc., Marlborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K160987 is the FDA 510(k) clearance record for ReWalk(TM), a class II device, cleared for Rewalk Robotics, Inc. on under FDA product code PHL (Powered Exoskeleton). FDA's definition for product code PHL reads: "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". FDA records list one 510(k) clearance for Rewalk Robotics, Inc. As of , FDA records show 2 recalls naming K160987.

Clearance record

Decision date
Received
(105 days to decision)
Product code
PHL Powered Exoskeleton
Regulation
21 CFR 890.3480
Device class
Class II
Review panel
Physical Medicine
Applicant
Rewalk Robotics, Inc. 33 Locke Dr., Marlborough MA
510(k) summary
Statement
Third party review
No

Clearances, product code PHL

Trailing 12 months
2 clearances under product code PHL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260