FDA applicant

Re Walk Robotics, Ltd.

Yokneam, IL3 decisions2019–20231 recall

FDA records 3 decisions for Re Walk Robotics, Ltd. (Yokneam, IL) from 2019 to 2023: 3 510(k) clearances. All are in product code PHL (Powered Exoskeleton). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 recall is 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 Re Walk Robotics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2020

2019high 1 (2020) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Re Walk Robotics, Ltd. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Re Walk Robotics, Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?