510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K073542Substantially Equivalent

Cycletrac CT-5000

Pt Products, LLC, Farmington Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073542 is the FDA 510(k) clearance record for CYCLETRAC CT-5000, a class II device, cleared for Pt Products, LLC on under FDA product code ITH (Equipment, Traction, Powered). FDA records list one 510(k) clearance for Pt Products, LLC. As of , FDA records show 2 recalls naming K073542.

Clearance record

Decision date
Received
(59 days to decision)
Product code
ITH Equipment, Traction, Powered
Regulation
21 CFR 890.5900
Device class
Class II
Review panel
Physical Medicine
Applicant
Pt Products, LLC 24543 Indoplex Cir., Farmington Hills MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ITH

Trailing 12 months

FDA records hold no clearances under product code ITH in the trailing twelve months.

FDA records show no clearances under product code ITH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ITH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260