Extentrac Elite
Catalogue number M100, listed by Advanced Back Technologies, United States, under Equipment, Traction, Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
2recalls on this 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 | Advanced Back Technologies, United States |
|---|---|
| FDA product code | ITH |
| Device type | Equipment, Traction, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5900 |
| 510(k) | K031996 |
| Record published | 2019-11-06 |
| Record revised | 2023-06-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M100 | 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 |
| clTrac | Zimmer Medizinsysteme Gmbh | 1 |
| SpineMED S200U Ultra Decompression System | Universal Pain Technology Canada Inc. | 1 |
| TM-400 | ITO Co., Ltd. | 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 |
|---|---|
| K031996 | 2004-07-23 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Advanced Back Technologies | 510(k) number | 2015-05-13 | Class II | Error in labeling | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs | 36 units | 2018-05-23 |
| Advanced Back Technologies | 510(k) number | 2015-05-13 | Class II | Error in labeling | Item is marketed for use in patients weighing up to 350 lbs, but the device was only approved for use in patients up to 300 lbs | 18 units | 2018-05-23 |
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.