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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 K811656
Device Name POWERED WHEELCHAIR
Applicant
The Oec Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Oec Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/12/1981
Decision Date 06/25/1981
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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