COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2— 510(k) K031618

Name: FDA 510(k) clearance K031618
Creator: U.S. Food and Drug Administration
Published: 2003-12-18

Substantially Equivalent

Comfort Orthopedic Co., Ltd.

FDA 510(k) clearance K031618 for COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2, Substantially Equivalent on 2003-12-18. 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: 2003-05-23
Decision date: 2003-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chia-Yi, TW

Download summary PDF View on FDA.gov ↗

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