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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Exoskeleton
510(k) Number K183152
Device Name Phoenix
Applicant
Us Bionics, Inc. (Dba Suitx)
4512 Hollis St.
Emeryville,  CA  94608
Applicant Contact Kelly Mettler
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave.
Suite B-257
San Diego,  CA  92110
Correspondent Contact Allison C. Komiyama
Regulation Number890.3480
Classification Product Code
PHL  
Date Received11/14/2018
Decision Date 04/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT03175055
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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