COMFORT STANDING WHEELCHAIR, HERO SERIES— 510(k) K102734

Name: FDA 510(k) clearance K102734
Creator: U.S. Food and Drug Administration
Published: 2010-12-14

Substantially Equivalent

Comfort Orthopedic Co., Ltd.

FDA 510(k) clearance K102734 for COMFORT STANDING WHEELCHAIR, HERO SERIES, Substantially Equivalent on 2010-12-14. Applicant: Comfort Orthopedic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Comfort Orthopedic Co., Ltd.
Product code: Code IPL
Device class: Class 2
Regulation: 21 CFR 890.3900
Advisory panel: Physical Medicine
Date received: 2010-09-22
Decision date: 2010-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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