# K051013: Spinemed S200B/S200C

- Pathway: 510(k) (Traditional)
- Applicant: Cert Health Sciences, LLC
- Decided: Apr 27, 2005 after 6 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)
- K001712: 3D Activetrac, The Saunders Group (2000) Summary page 1.
- K023160: DRX5000, Axiom Usa., Inc. (2002) Summary page 1.

## Indications for use
The SpineMED® System provides a program of treatments for relief from pain for those patients suffering with low back pain, neck pain or sciatica. Each treatment session consists of a physician prescribed treatment period on the SpineMED™ and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain, neck pain or sciatica. It relieves pain associated with herniated discs, bulging or 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/K051013
Methodology: https://510kreport.com/methodology