# K243366: DRX9000C-SL Cervical Spinal Decompression System

- Pathway: 510(k) (Traditional)
- Applicant: Excite Medical of Tampa Bay, LLC
- Decided: Jun 18, 2025 after 233 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: 2 generations back to K844385 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023160: DRX5000, Axiom Usa., Inc. (2002) Summary page 5.

## Indications for use
The DRX9000C-SL Cervical Spinal Decompression System provides a program of treatments for relief from pain for those patients suffering with neck pain. It is designed to apply spinal decompressive forces to the spine. Conditions that may be treated include neck pain associated with herniated discs, protruding intervertebral discs, degenerative disc disease, and posterior facet syndrome.

Source page: https://510kreport.com/device/K243366
Methodology: https://510kreport.com/methodology