# K031996: Extentrac Elite

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Back Technologies
- Decided: Jul 23, 2004 after 392 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894435 (1989). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980021: Extentrac, Advanced Back Technologies (1998). Our reading of the summary gave K890021, FDA’s number for Sterile Polyhesive PBS Dressing (Valleylab, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Extentrac”.
- K951622: Vax-D Therapeutic Table, Vat-Tech, Inc. (1996) Summary page 1.
- (no number) Galaxy 900 HS chiropractic table: named in the summary without a submission number
- (no number) Galaxy McManis Mobile-Trac Hydraulically-Controlled Table: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K010712: Dialysate Line with Connectors/RE-Use Wash-Out Lines, Molded Products, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K072064: Gravilax Traction System (2008), 0 descendants of its own

## Recalls of this device
- May 13, 2015 · Class II · Z-1717-2015: Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs
- May 13, 2015 · Class II · Z-1718-2015: Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs

## Indications for use
Conditions that may be treated include localized low back pain or peripheral radiation / sciatica due to: * Protruding or herniated intervertebral discs * Acute facet problems * Degenerative disc disease Federal law restricts this device to sale on or by the order of a licensed practitioner.

Source page: https://510kreport.com/device/K031996
Methodology: https://510kreport.com/methodology