# K190337: ReWalk Restore

- Pathway: 510(k) (Traditional)
- Applicant: Re Walk Robotics, Ltd.
- Decided: Jun 3, 2019 after 109 days
- Product code: PHL (Powered Exoskeleton)
- Device class: 2
- Regulation: 21 CFR 890.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN130034 (2014). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173530: Indego (R), Parker-Hannifin Corporation (2018) Summary page 5.

## Indications for use
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.

Source page: https://510kreport.com/device/K190337
Methodology: https://510kreport.com/methodology