Decompression of Choice
swing arm decompression table, 230V
1manufacturer
8catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Pivotal Health Solutions, United States |
|---|---|
| FDA product code | ITH |
| Device type | Equipment, Traction, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5900 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2022-08-11 |
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 |
|---|---|---|
| E9022-e | In distribution | |
| E9011-e | In distribution | |
| E9014 | In distribution | |
| E9015 | In distribution | |
| E9015-e | In distribution | |
| E9014-e | In distribution | |
| E9011 | In distribution | |
| E9022 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Chattanooga | DJO, LLC | 56 |
| 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 |
| 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 |
|---|---|
| K131983 | 2014-09-10 |
| K101889 | 2010-08-27 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-04-29 | Class II | Nonconforming Material/Component | This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but ha | 32 tables |
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.