# K081247: TM-400

- Pathway: 510(k) (Traditional)
- Applicant: Ito Co., Ltd.
- Decided: Aug 25, 2008 after 116 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: 5 generations back to K894435 (1989). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992545: TM-300 Traction System, Ito Co., Ltd. (1999) Summary page 1.
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction, Chattanooga Group (2006) Summary page 1.

## Indications for use
Use of the TM-400 powered traction device is indicated for the following: * Providing standard therapeutic and custom user-defined treatments in static, intermittent, progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). * Providing traction and mobilization of skeletal structures and skeletal muscles. * Relieving peripheral radiation / sciatica and pain associated with: Discs: Protruding, bulging, herniated and prolapsed discs Degenerative disc disease Discogenic pain Facets: Facet syndrome Posterior facet syndrome Acute facet problem Muscles & Joints: Muscle pain and spasms Degenerative joint disease Spinal Structures: Spinal root impingement Pinched nerves Compression fractures Pain: Back, lower back, neck, joint, sciatic and radicular pain Mobility & Flexibility: Hypomobility Limited spinal and joint flexibility

Source page: https://510kreport.com/device/K081247
Methodology: https://510kreport.com/methodology