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 System, Isokinetic Testing And Evaluation
510(k) Number K895236
Device Name MEDX REHABILITATION MACHINE
Applicant
Medx Corp.
1155 NE 77th St.
Ocala,  FL  32670
Applicant Contact WILLIAM JONES
Correspondent
Medx Corp.
1155 NE 77th St.
Ocala,  FL  32670
Correspondent Contact WILLIAM JONES
Regulation Number890.1925
Classification Product Code
IKK  
Date Received08/03/1989
Decision Date 09/14/1989
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
-
-