K-number	K120077
Device name	COMED K-SERIES MANUAL WHEELCHAIR
Applicant	Danyang Comed Healthcare Co., Ltd.
Product code	IOR
Device class	Class I
Decision date	May 14, 2012
Decision	Substantially Equivalent
Regulation	890.3850

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Source

View the full FDA submission: accessdata.fda.gov

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COMED K-SERIES MANUAL WHEELCHAIR

Everything you need for a 510(k) submission. Nothing you don't.