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 Device, Warning, Overload, External Limb, Powered
510(k) Number K931517
Device Name SAFE-STEP
Applicant
Lenjoy Engineering, Inc.
13402 S. Prairie Ave.
Hawthorne,  CA  90250
Correspondent
Lenjoy Engineering, Inc.
13402 S. Prairie Ave.
Hawthorne,  CA  90250
Regulation Number890.5575
Classification Product Code
IRN  
Date Received03/26/1993
Decision Date 03/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-