FDA applicant

Rewalk Robotics, Inc.

Marlborough, MA1 decision2016–20162 recalls

FDA records 1 decision for Rewalk Robotics, Inc. (Marlborough, MA) in 2016: 1 510(k) clearance. All are in product code PHL (Powered Exoskeleton). 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Rewalk Robotics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2020

2016high 1 (2017) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Rewalk Robotics, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Rewalk”

FDA records each applicant name separately; these may or may not be the same firm.

Rewalk Robotics Ltd. Dba Lifeward 1

Rewalk Robotics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Rewalk”