# K130249: Integrity Spinal Care System 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Integrity Life Sciences
- Decided: Feb 6, 2014 after 370 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: 4 generations back to K894435 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060735: DRX9000 True Spinal Decompression System, Axiom Worldwide, Inc. (2006) Summary page 1.

## Indications for use
The Integrity Spinal Care System 3.0 provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica.

Source page: https://510kreport.com/device/K130249
Methodology: https://510kreport.com/methodology