CYCLETRAC CT-5000


Device Classification Name

equipment, traction, powered

510(k) Number K073542
Device Name CYCLETRAC CT-5000
Applicant
PT PRODUCTS, LLC
24543 indoplex circle
farmington hills, 
MI 
48335

Applicant Contact michele conway
Correspondent
PT PRODUCTS, LLC
24543 indoplex circle
farmington hills, 
MI 
48335

Correspodent Contact michele conway
Regulation Number 890.5900
Classification Product Code
ITH  
Date Received 12/17/2007
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls