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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 K153543
Device Name WHILL Model M
Applicant
Whill, Inc.
285 Old County Rd., Suite 6
San Carlos,  CA  94070
Applicant Contact TERESE BOGUCKI
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/11/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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