HERO 1, MODEL LY-ESB220— 510(k) K031621

Name: FDA 510(k) clearance K031621
Creator: U.S. Food and Drug Administration
Published: 2004-01-22

Substantially Equivalent

Comfort Orthopedic Co., Ltd.

FDA 510(k) clearance K031621 for HERO 1, MODEL LY-ESB220, Substantially Equivalent on 2004-01-22. 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: 2004-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chia-Yi, TW

Download summary PDF View on FDA.gov ↗

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