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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 K130848
Device Name SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
Applicant
Shanghai Phoenix Medical Equipment Co., Ltd.
#188, Zhongfa Rd.
Zhujing Industrial Park
Jinshan District, Shanghai,  CN 201500
Applicant Contact Ke-Min Jen
Correspondent
Shanghai Phoenix Medical Equipment Co., Ltd.
#188, Zhongfa Rd.
Zhujing Industrial Park
Jinshan District, Shanghai,  CN 201500
Correspondent Contact Ke-Min Jen
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/26/2013
Decision Date 11/12/2013
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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