# K241822: ReWalk® 7 Personal Exoskeleton (50-20-0005)

- Pathway: 510(k) (Traditional)
- Applicant: Rewalk Robotics Ltd. Dba Lifeward
- Decided: Mar 12, 2025 after 261 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: 3 generations back to K160987 (2016). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221696: ReWalk P6.0, Re Walk Robotics, Ltd. (2023) Summary page 6.
- (no number) ReWalk® P6.0: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K160987: ReWalk (TM), Rewalk Robotics, Inc. (2016). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ReWalk@ 7 Personal Exoskeleton 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 in home and community settings with supervision of a specially certified 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 7 is intended for indoor and outdoor use: including standing and walking on level surfaces and mild slopes, and ascending and descending stairs and curbs.

Source page: https://510kreport.com/device/K241822
Methodology: https://510kreport.com/methodology