510(k) · Cleared
ClearedModel D Disc Force
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Medical Corp (Nam) · ITH Equipment, Traction, Powered
Cleared on Apr 3, 2008 as substantially equivalent to K981822 (Professional Distribution Systems, Inc., 1998) and 2 other predicates after a 148-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Apr 3, 2008
- Review
- 148 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894435 (1989). 10 ancestors in all, the oldest K844385 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 3 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 2 generations backK022602 DRX3000Axiom Usa., Inc. · 2003
- 1 generation backK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- This deviceK073132 Model D Disc ForceNorth American Medical Corp (Nam) · 2008
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 | K022602 | DRX3000 | Axiom Usa., Inc. | 2003 | — |
| −1 | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| 0 (this device) | K073132 | Model D Disc Force | North American Medical Corp (Nam) | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K981822 | DRS SystemSummary page 1…ITH Panel Code: 890 - Physical Medicine Predicate Devices: K981822 - DRS K023160 - DRX500 K060735 - DRX9000 Intended Use: T… | 1998 |
| * | K023160 | DRX5000Summary page 1…890 - Physical Medicine Predicate Devices: K981822 - DRS K023160 - DRX500 K060735 - DRX9000 Intended Use: The Model D provides a program of treatments for th… | 2002 |
| * | K060735 | DRX9000 True Spinal Decompression SystemSummary page 1…l Medicine Predicate Devices: K981822 - DRS K023160 - DRX500 K060735 - DRX9000 Intended Use: The Model D provides a program of treatments for the relief from pain for those patients suffering from… | 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 19 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 10 ancestors has a recall.
- 7 other devices also cite its predicate K981822.
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 Model D - Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back…
Read the full statement (109 words)
The Model D - Disc Force provides a program of traction type treatments for relief from pain for patients suffering with low back pain and neck pain. Each treatment consists of a physician prescribed treatment period on the Model D - Disc Force and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back or neck pain. Conditions that may be treated include neck and back pain associated with herniated discs, protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of inter-vertebral discs, that is, unloading due to distraction and positioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073132: Model D Disc Force.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073132
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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