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CYCLETRAC CT-5000

by Pt Products, LLC

510(k) K073542

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK073542 Date14 Feb 2008ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0341-2009 FDA Unclassified (pre-2012) initiated 29 Aug 2008 on shared 510(k) K073542
    • Terminated Z-0342-2009 FDA Unclassified (pre-2012) initiated 29 Aug 2008 on shared 510(k) K073542

    Under certain conditions, x-ray system may experience operational impairment.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITH
Device Class
Class II
Regulation
21 CFR Part 890.5900
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CYCLETRAC CT-5000 is a powered traction equipment device classified under the Physical Medicine specialty. It is designed for automated cervical traction therapy.

The device is supplied as a reusable unit and requires appropriate cleaning and maintenance between uses. It is intended for use in clinical settings under professional supervision and has received FDA 510(k) clearance under product code ITH, regulation number 890.5900, and device class 2.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CYCLETRAC CT-5000 used for?

    The CYCLETRAC CT-5000 is designed for automated cervical traction therapy, providing powered traction treatment in the Physical Medicine specialty for patients requiring mechanical neck traction under clinical supervision.

  • Is the CYCLETRAC CT-5000 a single-use or reusable device?

    The CYCLETRAC CT-5000 is supplied as a reusable unit, meaning it can be used multiple times provided it undergoes appropriate cleaning and maintenance between each use to ensure safety and functionality.

  • What regulatory pathway was used for the CYCLETRAC CT-5000?

    The CYCLETRAC CT-5000 received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device under product code ITH and regulation number 890.5900 for class II medical devices.

  • In what settings is the CYCLETRAC CT-5000 intended to be used?

    The device is intended for use in clinical settings under professional supervision, meaning it should only be operated by trained healthcare providers in environments such as clinics or rehabilitation centers where proper oversight is available.