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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Stair Climbing
510(k) Number K172601
Device Name Next Generation iBOT
Applicant
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Applicant Contact Roger Leroux
Correspondent
Deka Research & Development Corp.
340 Commercial St.
Manchester,  NH  03101
Correspondent Contact Roger Leroux
Regulation Number890.3890
Classification Product Code
IMK  
Date Received08/30/2017
Decision Date 03/02/2018
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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