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 K233695
Device Name Medical HAL Lower Limb Type (HAL-ML)
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 Received11/17/2023
Decision Date 05/07/2024
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
-
-