# K072064: Gravilax Traction System

- Pathway: 510(k) (Traditional)
- Applicant: Therapeutic Clinical Technologies, Inc.
- Decided: Apr 21, 2008 after 269 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: 3 generations back to K894435 (1989). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991835: Hang Ups Power II, Stl Intl., Inc. (1999) Summary page 1.
- K053503: Vax-D Genesis System (Therapeutic Table), Vax-D Medical Technologies USA, L.C. (2005) Summary page 1.
- K052453: Traction System, Digit-Trac 930, Ever Prosperous Instrument, Inc. (2006) Summary page 1.
- K031996: Extentrac Elite, Advanced Back Technologies (2004) Summary page 1.
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.

## Indications for use
The GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.

Source page: https://510kreport.com/device/K072064
Methodology: https://510kreport.com/methodology