# K991931: CTD Mark I Traction Device

- Pathway: 510(k) (Traditional)
- Applicant: Therasys, Inc.
- Decided: Aug 12, 1999 after 65 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CTD Mark I is a mobile, cervical, pneumatic pulling-traction device expressly used to perform traction and mobilization of the cervical muscles and vertebrae. It provides intermittent or continuous traction modes. The CTD Mark I when used as a cervical traction device is for clinical use only by prescription of a licensed physician.

Source page: https://510kreport.com/device/K991931
Methodology: https://510kreport.com/methodology