HAL for Medical Use(Lower Limb type)— 510(k) K201559

Name: FDA 510(k) clearance K201559
Creator: U.S. Food and Drug Administration
Published: 2020-10-02

Substantially Equivalent

Cyberdyne, Inc.

FDA 510(k) clearance K201559 for HAL for Medical Use(Lower Limb type), Substantially Equivalent on 2020-10-02. 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: 2020-06-10
Decision date: 2020-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tsukuba, JP

Download summary PDF View on FDA.gov ↗

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