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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 K111636
Device Name REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM
Applicant
Gunnell, Inc.
8440 State
P.O. Box 308
Millington,  MI  48746
Applicant Contact ANDREW EVANCHO
Correspondent
Gunnell, Inc.
8440 State
P.O. Box 308
Millington,  MI  48746
Correspondent Contact ANDREW EVANCHO
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/13/2011
Decision Date 04/03/2012
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
Recalls CDRH Recalls
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