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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
Recalls CDRH Recalls
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