510(k) · Cleared
ClearedTriton/Tru-Trac/TX/Triton DTS Traction
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · ITH Equipment, Traction, Powered
Cleared on Feb 24, 2006 as substantially equivalent to K051938 (Chattanooga Group, 2005) and 8 other predicates after a 99-day review. Its family tree reaches back 4 generations to 1989. 8 later devices descend from it.
- Decided
- Feb 24, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 4 generations to K894435 (1989). 19 ancestors in all, the oldest K834405 (1984). 8 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 3 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 2 generations backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- 1 generation backK030060 SpinemedCert Health Sciences, LLC · 2003
- This deviceK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · cites it directly · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · cites it directly · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
- Descendant · cites it directly · 0 of its ownK150695 ModpodHollywog, LLC · 2015
- Descendant · cites it directly · 0 of its ownK101889 Decompression of Choice and Neuro Decompression DevicePivotal Health Solutions · 2010 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · cites it directly1descendant
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · cites it directly0descendants
- K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 2 generations on0descendants
- K150695ModpodHollywog, LLC · 2015 · cites it directly0descendants
- K101889Decompression of Choice and Neuro Decompression DevicePivotal Health Solutions · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −3 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −2 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| −1 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| 0 (this device) | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +1 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +1 | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
| +2 | K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023 | — |
| +1 | K150695 | Modpod | Hollywog, LLC | 2015 | — |
| +1 | K101889 | Decompression of Choice and Neuro Decompression Device | Pivotal Health Solutions | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (9)
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 |
|---|---|---|---|
| * | K051938 | Triton/Tru-Trac/TX Traction DevicesSummary page 1…USUAL NAME: Powered Traction Equipment CLASSIFICATION Class 11 (Product Code ITH) PREDICATE DEVICES K051938 - Triton/ Tru-Trac/ TX Traction, K844385 - Eskotek EST Trac 401 Traction,… | 2005 |
| * | K844385 | Escotek Est Trac 401Summary page 1…Class 11 (Product Code ITH) PREDICATE DEVICES K051938 - Triton/ Tru-Trac/ TX Traction, K844385 - Eskotek EST Trac 401 Traction, K992733 - Akron ATP9,… | 1985 |
| * | K992733 | Akron ATP9 Traction MachineSummary page 1…K051938 - Triton/ Tru-Trac/ TX Traction, K844385 - Eskotek EST Trac 401 Traction, K992733 - Akron ATP9, K053503 - VAX-D Genesis System, K03… | 1999 |
| * | K053503 | Vax-D Genesis System (Therapeutic Table) Cleared while this submission was under review Summary page 1…K844385 - Eskotek EST Trac 401 Traction, K992733 - Akron ATP9, K053503 - VAX-D Genesis System, K031862 - SpineRx-LDM, K0… | 2005 |
| * | K031862 | Spinerx-LDMSummary page 1…K992733 - Akron ATP9, K053503 - VAX-D Genesis System, K031862 - SpineRx-LDM, K001361 - Jilco, K030060 - SpineMe… | 2003 |
| * | K001361 | Jilco Traction-Flexion ChairSummary page 1…K053503 - VAX-D Genesis System, K031862 - SpineRx-LDM, K001361 - Jilco, K030060 - SpineMed, K972487 - EMG Retrai… | 2000 |
| * | K030060 | SpinemedSummary page 1…s System, K031862 - SpineRx-LDM, K001361 - Jilco, K030060 - SpineMed, K972487 - EMG Retrainer, K881416 - My… | 2003 |
| * | K972487 | Emg RetrainerSummary page 1…SpineRx-LDM, K001361 - Jilco, K030060 - SpineMed, K972487 - EMG Retrainer, K881416 - MyoTrac DEVICE DESCRIPTION: The Chattanooga Group powered tr… | 1997 |
| * | K881416 | MyotracSummary page 1…lco, K030060 - SpineMed, K972487 - EMG Retrainer, K881416 - MyoTrac DEVICE DESCRIPTION: The Chattanooga Group powered traction device consists of an electric traction treatment unit, an… | 1988 |
What descends from it? (8)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K151640 (Enraf-Nonius, B.V., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051938.
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?
The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be…
Read the full statement (172 words)
The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles.
The Triton/ Tru-Trac/TX/Triton DTS Traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns., cycles and functions.
The Triton/ Tru-Trac/ TX/ Triton DTS Traction devices with the optional EMG (a.k.a. sEMG) biofeedback feature may be used to relieve peripheral radiation/sciatica and pain associated with:
Protruding discs
Bulging discs
Herniated discs
Degenerative disc disease
Posterior facet syndrome
Acute facet problems
Radicular pain
Prolapsed discs
Spinal root impingement
Hypomobility
Degenerative joint disease
Facet syndrome
Compressions fractures
Joint pain
Discogenic pain
EMG (a.k.a. sEMG)
Determination of the activation magnitude and timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
Determination of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053223: Triton/Tru-Trac/TX/Triton DTS Traction.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053223
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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