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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 K001252
Device Name MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
Applicant
Maxhealth Corp.
4655 Kirkwood Court
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Maxhealth Corp.
4655 Kirkwood Court
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number890.3850
Classification Product Code
IOR  
Date Received04/19/2000
Decision Date 06/12/2000
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
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