510(k) · Cleared
ClearedGravilax Traction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therapeutic Clinical Technologies, Inc. · ITH Equipment, Traction, Powered
Cleared on Apr 21, 2008 as substantially equivalent to K991835 (Stl Intl., Inc., 1999) and 4 other predicates after a 269-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Apr 21, 2008
- Review
- 269 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K894435 (1989). 14 ancestors in all, the oldest K821002 (1982). No later device cites it as a predicate yet.
- Root · 3 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 2 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 1 generation backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- This deviceK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −2 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −1 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| 0 (this device) | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K991835 | Hang Ups Power IISummary page 1…r traction devices which achieve their effect through the force of gravity and/or mechanical means, including the following: HangUps InvertAlign; STL International Inc. K991835; BAX-D Genesis System; VAD-D Medical Technology Services, LLC. K053503; Digit-Trac 930 Traction System; Ever Prosperous Instrumen… | 1999 |
| * | K053503 | Vax-D Genesis System (Therapeutic Table)Summary page 1…ity and/or mechanical means, including the following: HangUps InvertAlign; STL International Inc. K991835; BAX-D Genesis System; VAD-D Medical Technology Services, LLC. K053503; Digit-Trac 930 Traction System; Ever Prosperous Instrument, Inc. K052453; Extentrac Elite; Advanced Back Technologies, Inc. K031… | 2005 |
| * | K052453 | Traction System, Digit-Trac 930Summary page 1…; STL International Inc. K991835; BAX-D Genesis System; VAD-D Medical Technology Services, LLC. K053503; Digit-Trac 930 Traction System; Ever Prosperous Instrument, Inc. K052453; Extentrac Elite; Advanced Back Technologies, Inc. K031996; and DRS System; Professional Distribution Systems, Inc. K981822. Ind… | 2006 |
| * | K031996 | Extentrac EliteSummary page 1…-D Medical Technology Services, LLC. K053503; Digit-Trac 930 Traction System; Ever Prosperous Instrument, Inc. K052453; Extentrac Elite; Advanced Back Technologies, Inc. K031996; and DRS System; Professional Distribution Systems, Inc. K981822. Indications for Use: The GraviLax Traction System is intended… | 2004 |
| * | K981822 | DRS SystemSummary page 1…tion System; Ever Prosperous Instrument, Inc. K052453; Extentrac Elite; Advanced Back Technologies, Inc. K031996; and DRS System; Professional Distribution Systems, Inc. K981822. Indications for Use: The GraviLax Traction System is intended for use in exerting therapeutic pulling force on the patient's bo… | 1998 |
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 19 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 GraviLax Traction System is intended for use in exerting therapeutic pulling forces on the patient's body. The device utilizes a cylindrical hot tub in which the patient is suspended vertically by a shoulder harness and which contains salt water whose salinity is adjusted to a specific gravity of approximately 1.2 providing an increased natural buoyancy to the user's body. Decompressive force (unloading due to distraction and positioning) to the sacral, lumbar and thoracic spine is achieved by application of suitable weights to the patient's ankles This device is for prescription use only and is limited to use by qualified personnel in a suitably equipped treatment facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072064: Gravilax Traction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072064
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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