# K073542: Cycletrac CT-5000

- Pathway: 510(k) (Traditional)
- Applicant: Pt Products, LLC
- Decided: Feb 14, 2008 after 59 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894435 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction, Chattanooga Group (2006) Summary page 1.
- K001712: 3D Activetrac, The Saunders Group (2000) Summary page 1.
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.

## Recalls of this device
- Aug 29, 2008 · Not classified · Z-0341-2009: Under certain conditions, x-ray system may experience operational impairment.
- Aug 29, 2008 · Not classified · Z-0342-2009: Under certain conditions, x-ray system may experience operational impairment.

## Indications for use
The CycleTrac® Automated Cervical Traction Unit provides a primary treatment modality for the management of neck and back pain. Intermittent/static cervical traction results in cervical disk decompression (unloading due to distraction and positioning) which provides relief of pain associated with a variety of conditions involving anatomical dysfunctions of the spine, including protruding or herniated intervertebral discs, degenerative discs and acute facet problems.

Source page: https://510kreport.com/device/K073542
Methodology: https://510kreport.com/methodology