Medical HAL Lower Limb Type (HAL-ML)— 510(k) K233695

Name: FDA 510(k) clearance K233695
Creator: U.S. Food and Drug Administration
Published: 2024-05-07

Substantially Equivalent

Cyberdyne, Inc.

FDA 510(k) clearance K233695 for Medical HAL Lower Limb Type (HAL-ML), Substantially Equivalent on 2024-05-07. Applicant: Cyberdyne, Inc.. Device class: 2.

Clearance details

Applicant: Cyberdyne, Inc.
Product code: Code PHL
Device class: Class 2
Regulation: 21 CFR 890.3480
Advisory panel: Physical Medicine
Date received: 2023-11-17
Decision date: 2024-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tsukuba, JP

Download summary PDF View on FDA.gov ↗

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More clearances from Cyberdyne, Inc.

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K201559 — HAL for Medical Use(Lower Limb type)2020-10-02
K171909 — HAL for Medical Use (Lower Limb Type)2017-12-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.