510(k) Report

FDA applicant

Cyberdyne, Inc.

Tsukuba, JP3 decisions2017–20240 recalls

FDA records 3 decisions for Cyberdyne, Inc. (Tsukuba, JP) from 2017 to 2024: 3 510(k) clearances. All are in product code PHL (Powered Exoskeleton). Its devices cite 3 predicates, 2 of them its own earlier devices. No 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 Cyberdyne, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2017: 12020: 12024: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Cyberdyne, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PHLPowered Exoskeleton3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. · 20241cites it
  • K201559HAL for Medical Use (Lower Limb type)Cyberdyne, Inc. · 20201cites it
  • K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. · 20171cites it

What has FDA decided for it lately?

  • K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc. · 2024
  • K201559HAL for Medical Use (Lower Limb type)Cyberdyne, Inc. · 2020
  • K171909HAL for Medical Use (Lower Limb Type)Cyberdyne, Inc. · 2017

All 3 as Cyberdyne, Inc. →