# K091540: MTD 4000

- Pathway: 510(k) (Abbreviated)
- Applicant: Mettler Electronics Corp.
- Decided: Oct 8, 2009 after 135 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: 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)
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction, Chattanooga Group (2006) Summary page 1.
- K992545: TM-300 Traction System, Ito Co., Ltd. (1999) Summary page 1.
- K051938: Triton/Tru-Trac/TX Traction Devices, Chattanooga Group (2005) Summary page 3.

## Recalls of this device
- Apr 14, 2011 · Not classified · Z-2580-2011: The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD400

## Indications for use
The MTD 4000 traction device provides traction and mobilization of skeletal structures and skeletal muscles. The MTD 4000 may be used to relieve peripheral radiation/sciatica and pain associated with: Protruding discs Bulging discs Herniated discs Degenerative disc disease Posterior facet syndrome Acute facet problems Radicular pain Prolapsed discs Spinal root impingement Hypomobility Degenerative joint disease Facet syndrome Compressions fractures Joint pain EDiscogenic pain

Source page: https://510kreport.com/device/K091540
Methodology: https://510kreport.com/methodology