510(k) · Cleared
ClearedExtentrac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Back Technologies · JFB Table, Physical Therapy, Multi Function
Cleared on May 11, 1998 as substantially equivalent to K844233 (Chattanooga Group, Inc., 1984) after a 126-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it.
- Decided
- May 11, 1998
- Review
- 126 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K844233 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK844233 Autotraction TableChattanooga Group, Inc. · 1984
- This deviceK980021 ExtentracAdvanced Back Technologies · 1998
- Descendant · cites it directly · 1 of its ownK031996 Extentrac EliteAdvanced Back Technologies · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K844233 | Autotraction Table | Chattanooga Group, Inc. | 1984 | — |
| 0 (this device) | K980021 | Extentrac | Advanced Back Technologies | 1998 | — |
| +1 | K031996 | Extentrac Elite | Advanced Back Technologies | 2004 | 2 |
| +2 | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 JFB? 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 JFB device
- #1 K240168 N7-Sscore 9.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844233 | Autotraction TableSummary page 1…a, D.C. Phone: 516-364-1717 Fax: 516-364-1998 The legally marketed device or predicate, to which I am claiming substantial equivalence : AUTO-TRAC TABLE 510(k) NUMBER K844233 Device/Trade Name : EXTENTRAC Common Name : Physical Therapy Table, Multipurpose Classification Name : Multipurpose Physical The… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031996 | Extentrac Elite | 2004 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K031996 (Advanced Back Technologies, 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JFB devicesJFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFB
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFB
No recall names JFB since 2007.
Adverse event reports per year · JFB
1in 2024
MAUDE reports naming product code JFB, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 3 | 162 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Extentrac provides traction, for the relief of a variety of conditions involving anatomical dysfunctions of the lumber spine including :
- localized low back pain
-peripheral radiation (radicular pain)
-protruding or hemiated intervertebral discs.
-acute facet probhlems
- .-degenerative disc disease
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980021 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980021: Extentrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980021
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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