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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 K001909
Device Name PLAINSENSE WHEELCHAIR
Applicant
Plainsense Wheelchairs, Inc.
2919 Bentwood Dr.
Marietta,  GA  30062
Correspondent
Plainsense Wheelchairs, Inc.
2919 Bentwood Dr.
Marietta,  GA  30062
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/22/2000
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
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