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 K201559
Device Name HAL for Medical Use(Lower Limb type)
Applicant
Cyberdyne Inc.
2-2-1 Gakuen-Minami
Tsukuba,  JP 305-0818
Applicant Contact Yohei Suzuki
Correspondent
Cyberdyne Inc.
2-2-1 Gakuen-Minami
Tsukuba,  JP 305-0818
Correspondent Contact Yohei Suzuki
Regulation Number890.3480
Classification Product Code
PHL  
Subsequent Product Code
HCC  
Date Received06/10/2020
Decision Date 10/02/2020
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
-
-