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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 K022700
Device Name DELUXE MANUAL WHEELCHAIR HW 4000
Applicant
FOREVER YOUNG ENT. CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,,  CN 300
Applicant Contact JEN KE-MIN
Correspondent
FOREVER YOUNG ENT. CO., LTD.
NO. 58 FU-CHIUN ST.
HSIN-CHU CITY,,  CN 300
Correspondent Contact JEN KE-MIN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/13/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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