510(k) · Cleared
ClearedTM-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · ITH Equipment, Traction, Powered
Cleared on Aug 25, 2008 as substantially equivalent to K992545 (Ito Co., Ltd., 1999) and 1 other predicate after a 116-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Aug 25, 2008
- Review
- 116 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894435 (1989). 21 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 deviceK081247 TM-400Ito Co., Ltd. · 2008
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) | K081247 | TM-400 | Ito Co., Ltd. | 2008 | — |
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 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K992545 | TM-300 Traction SystemSummary page 1…n Name: Powered Traction Device Classification Number: 21 CFR 890.5900 Class: II Predicate Devices: K992545 -1'M-300 Traction System (ITO. CO., LTD.) K053223 TX Traction (CHATTANOOGA GROUP) Device Descr… | 1999 |
| * | K053223 | Triton/Tru-Trac/TX/Triton DTS TractionSummary page 1…21 CFR 890.5900 Class: II Predicate Devices: K992545 -1'M-300 Traction System (ITO. CO., LTD.) K053223 TX Traction (CHATTANOOGA GROUP) Device Description: The TM-400 is a simple to use powered traction unit that offers static, int… | 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 5 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 21 ancestors has a recall of any class.
- 1 other device also cites its predicate K992545.
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?
Use of the TM-400 powered traction device is indicated for the following: * Providing standard therapeutic and custom user-defined treatments in static, intermittent, progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). * Providing traction and mobilization of skeletal structures and skeletal…
Read the full statement (131 words)
Use of the TM-400 powered traction device is indicated for the following:
* Providing standard therapeutic and custom user-defined treatments in static, intermittent, progressive, regressive, cyclical and combination distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder).
* Providing traction and mobilization of skeletal structures and skeletal muscles.
* Relieving peripheral radiation / sciatica and pain associated with:
Discs:
Protruding, bulging, herniated and prolapsed discs
Degenerative disc disease
Discogenic pain
Facets:
Facet syndrome
Posterior facet syndrome
Acute facet problem
Muscles & Joints:
Muscle pain and spasms
Degenerative joint disease
Spinal Structures:
Spinal root impingement
Pinched nerves
Compression fractures
Pain:
Back, lower back, neck, joint, sciatic and radicular pain
Mobility & Flexibility:
Hypomobility
Limited spinal and joint flexibility
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081247 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081247: TM-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081247
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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