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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 K002167
Device Name KARMAN WHEELCHAIR
Applicant
KARMAN HEALTHCARE, INC.
137 8TH AVE., #F
LA PUENTE,  CA  91746
Applicant Contact ALEX C HORNG
Correspondent
KARMAN HEALTHCARE, INC.
137 8TH AVE., #F
LA PUENTE,  CA  91746
Correspondent Contact ALEX C HORNG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/18/2000
Decision Date 08/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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