# K101889: Decompression of Choice and Neuro Decompression Device

- Pathway: 510(k) (Traditional)
- Applicant: Pivotal Health Solutions
- Decided: Aug 27, 2010 after 51 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 2.
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction, Chattanooga Group (2006) Summary page 1.

## Recalls of this device
- Apr 29, 2024 · Class II · Z-2326-2024: This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E71

## Indications for use
The Decompression' of Choice (DOG) and MAAR 2K10 is a non invasive method of applying distractive forces to the spine through controlled tensions. It is designed to apply decompression (decompression is unloading due to distraction and positioning and/or as non-surgical in nature) forces to intervertebrall discs. The Decompression' of Choice (DOC) and AAAR 2K1 0 may be used for back pain, neck pain, herniated discs, protruding discs, degenerative disc disease, sciatica and posterior facet syndromes.

Source page: https://510kreport.com/device/K101889
Methodology: https://510kreport.com/methodology