# K131983: Itrac Cervical Traction System

- Pathway: 510(k) (Traditional)
- Applicant: Pivotal Health Solutions
- Decided: Sep 10, 2014 after 439 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063353 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063353: Ctbox Cervical/Lumbar Traction, Circular Traction Supply, Inc. (2007) Summary page 6.

## Indications for use
The iTrac c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Source page: https://510kreport.com/device/K131983
Methodology: https://510kreport.com/methodology