510(k) · Cleared
ClearedErgo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ergo-Flex Technologies, LLC · ITH Equipment, Traction, Powered
Cleared on Feb 22, 2024 as substantially equivalent to K053223 (Chattanooga Group, 2006) after a 791-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Feb 22, 2024
- Review
- 791 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894435 (1989). 20 ancestors in all, the oldest K834405 (1984). No later device cites it as a predicate yet.
- Root · 5 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 4 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 3 generations backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- 2 generations backK030060 SpinemedCert Health Sciences, LLC · 2003
- 1 generation backK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- This deviceK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −4 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −3 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| −2 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| −1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| 0 (this device) | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K053223 | Triton/Tru-Trac/TX/Triton DTS TractionSummary page 10…reviously cleared by the FDA via the 510K process. 510(k) Number Predicate Device Name Manufacturer K053223 Triton/Tru-Trac/TX/ Chattanooga Group Triton DTS… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- None of the 20 ancestors has a recall.
- 6 other devices also cite its predicate K053223.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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 Back on Trac (BOTGEN1) and Cervi-Trac Systems are intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder). Back on Trac The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)”. The device may…
Read the full statement (214 words)
The Back on Trac (BOTGEN1) and Cervi-Trac Systems are intended for use in professional healthcare facilities, to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder).
Back on Trac
The Back on Trac (BOTGEN1) is intended for use to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, shoulder)”. The device may be used to manage and reduce pain associated with the following conditions:
• facet syndrome,
• herniated disc,
• protruding disc,
• extruded disc,
• sciatica,
• spondylosis (degenerative disc disease & facet syndrome),
• joint pain.
Vibration and heat are available options that can be utilized with the Back on Trac (BOTGEN1) at the discretion of the healthcare professional. When activated, the vibration mode can provide muscle relaxation and temporary relief of minor aches and pains. The heat mode, when activated, can provide temporary relief of minor aches and pains. The local warmth temporarily stimulates local blood circulation in your lower back.
Cervi-Trac
The Cervi-Trac is intended for use as an accessory to the Back on Trac (BOTGEN1) to relieve pressures on structures that may be causing pain of skeletal or muscular origin. The Cervi-Trac accessory focuses specifically on the cervical region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214037: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214037
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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