# K023160: DRX5000

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Usa., Inc.
- Decided: Dec 20, 2002 after 88 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 K844385 (1985). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001712: 3D Activetrac, The Saunders Group (2000)
- K844385: Escotek Est Trac 401, Nor-Am Patient Care Products, Inc. (1985) Summary page 1.

## Most influential descendants
- K243366: DRX9000C-SL Cervical Spinal Decompression System (2025), 0 descendants of its own
- K103248: Integrity Spinal Care System (2011), 0 descendants of its own
- K073132: Model D Disc Force (2008), 0 descendants of its own
- K051013: Spinemed S200B/S200C (2005), 0 descendants of its own

## Indications for use
The DRX5000 provides a program of treatments for relief from pain for those patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the DRX5000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck pain and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Source page: https://510kreport.com/device/K023160
Methodology: https://510kreport.com/methodology