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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 K201539
Device Name Keeogo Dermoskeleton System
Applicant
B-Temia Inc.
4780, rue St-Felix-unite 105
St Augustin de Desmaure,  CA G3A 2J9
Applicant Contact Alexandre Jokic
Correspondent
Covington & Burling LLP
850 10th St NW,
Washington,  DC  20001
Correspondent Contact Kristin Davenport
Regulation Number890.3480
Classification Product Code
PHL  
Date Received06/09/2020
Decision Date 09/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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