HAL for Medical Use (Lower Limb Type)— 510(k) K171909

Name: FDA 510(k) clearance K171909
Creator: U.S. Food and Drug Administration
Published: 2017-12-17

Substantially Equivalent

Cyberdyne, Inc.

FDA 510(k) clearance K171909 for HAL for Medical Use (Lower Limb Type), Substantially Equivalent on 2017-12-17. 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: 2017-06-26
Decision date: 2017-12-17
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.