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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K091482
Device Name HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
Applicant
Danyang Huayi Medical Supply & Equipment Co, Ltd.
3119 Brick Ln.
Decatur,  GA  30033
Applicant Contact JIUGUANG (JOE) SONG
Correspondent
Danyang Huayi Medical Supply & Equipment Co, Ltd.
3119 Brick Ln.
Decatur,  GA  30033
Correspondent Contact JIUGUANG (JOE) SONG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/19/2009
Decision Date 07/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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