Panels › Physical Medicine › Product code ITH · Class 2
Equipment, Traction, Powered
Regulation 890.5900
0510(k)s in 12 months (71 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in ITH
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Back Technologies | 1 | 2 |
| North American Medical Corp (Nam) | 3 | 0 |
| Pivotal Health Solutions | 2 | 1 |
| Axiom Usa., Inc. | 2 | 0 |
| Axiom Worldwide, Inc. | 2 | 0 |
| Cert Health Sciences, LLC | 2 | 0 |
| Chattanooga Group | 2 | 0 |
| Ever Prosperous Instrument, Inc. | 2 | 0 |
| Excite Medical of Tampa Bay, LLC | 2 | 0 |
| Ito Co., Ltd. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2024 | Pivotal Health Solutions, Inc. Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment. Open, Classified |
ITH | K101889 |
| Jun 5, 2015 | Advanced Back Technologies, Inc. Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction) Terminated |
ITH | K031996 |
| Jun 5, 2015 | Advanced Back Technologies, Inc. Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction) Terminated |
ITH | K031996 |
| Apr 2, 2012 | Spinetronics, LLC Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By Spinetronics***Note: "Decompression" as used herein Terminated |
ITH | None listed |
| Jun 17, 2011 | Mettler Electronics Corp MTD 4000 - Mettler Traction Decompression System, Model: ME 4000
Product Usage: Provide traction and mobilization of skeletal structures and skeletal muscles Terminated |
ITH | K091540 |
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