# K160987: ReWalk (TM)

- Pathway: 510(k) (Special)
- Applicant: Rewalk Robotics, Inc.
- Decided: Jul 22, 2016 after 105 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200032: ReWalk P6.0 (2020), 3 descendants of its own
- K221696: ReWalk P6.0 (2023), 2 descendants of its own
- K254198: Trexo Theo (2026), 0 descendants of its own
- K241822: ReWalk® 7 Personal Exoskeleton (50-20-0005) (2025), 0 descendants of its own

## Recalls of this device
- Feb 28, 2020 · Class II · Z-1553-2021: ReWalk Robotics received two complaints (one in the US; one in the Germany), which alleged that the ReWalk device waistpack (which is the location of the Li-Ion battery packs) caught fire while being 
- Aug 14, 2017 · Class II · Z-0944-2018: Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula.

## Indications for use
The ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K160987
Methodology: https://510kreport.com/methodology