# DEN130034: Rewalk

- Pathway: De Novo (Direct)
- Applicant: Argo Medical Technologies, Inc.
- Decided: Jun 26, 2014 after 374 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
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K143690: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (2016), 14 descendants of its own
- K161443: Ekso™ (version 1.1) and Ekso GT™ (version 1.2) (2016), 12 descendants of its own
- K152416: Indego (2016), 7 descendants of its own
- K171334: Indego (2017), 6 descendants of its own
- K173530: Indego (R) (2018), 5 descendants of its own

## Indications for use
The Argo 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/DEN130034
Methodology: https://510kreport.com/methodology