TM-400
Traction Device
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JM Medical Co., Ltd. | Liaocheng | Shandong | Contract manufacturer | 25 |
Record
| Listed by | ITO Co., Ltd., Japan |
|---|---|
| FDA product code | ITH |
| Device type | Equipment, Traction, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5900 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K081247 |
| Record published | 2016-09-24 |
| Record revised | 2023-11-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TM-400 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 56 |
| Decompression of Choice | Pivotal Health Solutions | 8 |
| SpineMED Decompression System | Universal Pain Technology Canada Inc. | 5 |
| Antalgic Trak | Antalgic-Trak | 3 |
| Extentrac Elite | Advanced Back Technologies | 1 |
| clTrac | Zimmer Medizinsysteme Gmbh | 1 |
| SpineMED S200U Ultra Decompression System | Universal Pain Technology Canada Inc. | 1 |
| Dynatron TX900+ Traction System | Dynatronics Corp. | 1 |
| Repex | Hill Laboratories | 1 |
| Modpod | Hollywog, LLC | 1 |
| MTD 4000 Digital Traction | Mettler Electronics Corp. | 1 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 1 |
Showing 12 of 16. All products under Equipment, Traction, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081247 | 2008-08-25 |
| K992545 | 1999-09-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.