# K992545: TM-300 Traction System

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Sep 1, 1999 after 33 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K894435 (1989). 4 ancestors in all.
2 later devices descend from it; 2 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)
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K091540: MTD 4000 (2009), 0 descendants of its own
- K081247: TM-400 (2008), 0 descendants of its own

## Recalls of this device
- Jul 13, 2005 · Not classified · Z-1444-05: The traction device may malfunction, producing oscillation and a jerking motion.

## Indications for use
The TM-300 Traction System is indicated for relief of pain in cases of low back pain. Each treatment consists of a physician-prescribed session designed to provide static, intermittent, or cycling distraction forces to relieve pressure on structures that may be causing low back pain. The TM-300 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/K992545
Methodology: https://510kreport.com/methodology