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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transport, Patient, Powered
510(k) Number K103122
Device Name C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
Applicant
Aat Alber Antriebstechnik GmbH
2611 Shark Cir.
Texas City,  TX  77591
Applicant Contact STEFANIE D BANKSTON
Correspondent
Aat Alber Antriebstechnik GmbH
2611 Shark Cir.
Texas City,  TX  77591
Correspondent Contact STEFANIE D BANKSTON
Regulation Number890.5150
Classification Product Code
ILK  
Date Received10/21/2010
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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