510(k) · Cleared
Recalled · Class II · 2015Extentrac Elite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Back Technologies · ITH Equipment, Traction, Powered
Cleared on Jul 23, 2004 as substantially equivalent to K980021 (Advanced Back Technologies, 1998) and 1 other predicate after a 392-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 23, 2004
- Review
- 392 days
- Class
- Class II
- Product code
- ITH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894435 (1989). 4 ancestors in all, the oldest K844233 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 1 generation backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- This deviceK031996 Extentrac EliteAdvanced Back Technologies · 2004
- Descendant · cites it directly · 0 of its ownK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K072064Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −1 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| 0 (this device) | K031996 | Extentrac Elite | Advanced Back Technologies | 2004 | — |
| +1 | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980021 | Extentrac 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”. | 1998 |
| * | K951622 | Vax-D Therapeutic TableSummary page 1…870R Substantial Equivalent to the following Predicate Devices: * Extentrac, 5 10O(k) Numnber-K890021 * Vax-D Therapeutic table - K95 1622 * 3D Acti veTrac, 5 10(k) n umber K01 712 * Galaxy 900 HS chiropractic table [Class I exempt] * Galaxy McManis… | 1996 |
| Kept off the family tree | K010712 | FDA’s K010712 is Dialysate Line with Connectors/RE-Use Wash-Out Lines Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | — | Galaxy 900 HS chiropractic table Named without a submission number | |
| * | — | Galaxy McManis Mobile-Trac Hydraulically-Controlled Table Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072064 | Gravilax Traction System | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2015 | Class II | Z-1717-2015 | Error in labeling | 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 | Error in labeling | 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072064 (Therapeutic Clinical Technologies, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031996: Extentrac Elite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031996
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026