# K022602: DRX3000

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Usa., Inc.
- Decided: Jan 23, 2003 after 170 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 K894435 (1989). 4 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010292: DRX 2000, Axiom Worldwide, Inc. (2001)
- K844385: Escotek Est Trac 401, Nor-Am Patient Care Products, Inc. (1985) Summary page 1.
- K951622: Vax-D Therapeutic Table, Vat-Tech, Inc. (1996) Summary page 1.

## Most influential descendants
- K060735: DRX9000 True Spinal Decompression System (2006), 3 descendants of its own
- K243775: True Non-Surgical Spinal Decompression System (DRX9000-SL) (2025), 0 descendants of its own
- K130249: Integrity Spinal Care System 3.0 (2014), 0 descendants of its own
- K073132: Model D Disc Force (2008), 0 descendants of its own

## Indications for use
The DRX3000 provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment consists of a physician prescribed treatment period on the DRX3000 and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves 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/K022602
Methodology: https://510kreport.com/methodology