Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K200032
Device Name ReWalk P6.0
Applicant
Re Walk Robotics , Ltd.
3 Hetnufa St., Pob Box-161
Yokneam,  IL 2069203
Applicant Contact Ofir Koren
Correspondent
Re Walk Robotics , Ltd.
3 Hetnufa St., Pob Box-161
Yokneam,  IL 2069203
Correspondent Contact Ofir Koren
Regulation Number890.3480
Classification Product Code
PHL  
Date Received01/07/2020
Decision Date 05/26/2020
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-