• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name powered exoskeleton
510(k) Number K201539
Device Name Keeogo Dermoskeleton System
B-Temia Inc.
4780, rue St-Felix-unite 105
St Augustin de Desmaure,  CA G3A 2J9
Applicant Contact Alexandre Jokic
Covington & Burling LLP
850 10th St NW,
Washington,  DC  20001
Correspondent Contact Kristin Davenport
Regulation Number890.3480
Classification Product Code
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