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 Equipment, Traction, Powered
510(k) Number K073542
Device Name CYCLETRAC CT-5000
Applicant
Pt Products, LLC
24543 Indoplex Cir.
Farmington Hills,  MI  48335
Applicant Contact MICHELE CONWAY
Correspondent
Pt Products, LLC
24543 Indoplex Cir.
Farmington Hills,  MI  48335
Correspondent Contact MICHELE CONWAY
Regulation Number890.5900
Classification Product Code
ITH  
Date Received12/17/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-