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510(k) K073542

CYCLETRAC CT-5000 by Pt Products, LLC — Product Code ITH

K073542 is an FDA 510(k) premarket notification submitted by Pt Products, LLC for the device "CYCLETRAC CT-5000". The FDA issued a decision of Substantially Equivalent on February 14, 2008. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2008
Date Received
December 17, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

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  • K130249 — INTEGRITY SPINAL CARE SYSTEM 3.0 (February 6, 2014)
  • K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (February 1, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)

FDA data resources