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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, powered
510(k) Number K022539
Device Name PHFW-10
Applicant
PIHSIANG MACHINERY MFG. CO. LTD.
1101 ILLINOIS
P.O. BOX 187
NEODESHA,  KS  66757
Applicant Contact CHRIS TINSLEY
Correspondent
PIHSIANG MACHINERY MFG. CO. LTD.
1101 ILLINOIS
P.O. BOX 187
NEODESHA,  KS  66757
Correspondent Contact CHRIS TINSLEY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/01/2002
Decision Date 11/19/2002
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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