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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 K041814
Device Name FS SERIES WHEELCHAIR
Applicant
Foshan Dongfang Medical Equipment Manufactory(Ltd)
2 Baohua Industrial Park Av.
Guilan Rd. Nanhai District
Foshan, Guangdong Province,  CN 528252
Applicant Contact PANG JIANXUN
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/06/2004
Decision Date 07/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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