# K221696: ReWalk P6.0

- Pathway: 510(k) (Traditional)
- Applicant: Re Walk Robotics, Ltd.
- Decided: Mar 2, 2023 after 265 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: 2 generations back to K160987 (2016). 2 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K200032: ReWalk P6.0, Re Walk Robotics, Ltd. (2020) Summary page 5.

## Most influential descendants
- K254198: Trexo Theo (2026), 0 descendants of its own
- K241822: ReWalk® 7 Personal Exoskeleton (50-20-0005) (2025), 0 descendants of its own

## Indications for use
The ReWalk® P6.0 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 P6.0 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/K221696
Methodology: https://510kreport.com/methodology