Equipment, Traction, Powered
Physical Medicine · 21 CFR 890.5900
Recent MDR events
53 adverse event reports on file
- MEDLINEJul 15, 2026MalfunctionMedline Industried Lp1417592-2026-05912
- DECOMPRESSION OF CHOICEJul 15, 2026InjuryPivotal Health Solutions, Inc3007278668-2026-00005
- DECOMPRESSION OF CHOICEOct 15, 2025MalfunctionPivotal Health Solutions, Inc3007278668-2025-00002
- CHATTANOOGAOct 1, 2025MalfunctionDjo Llc9616086-2025-00062
- DRX9000Jun 2, 2025InjuryExcite Medical Of Tampa Bay LlcMW5170963
- CHATTANOOGANov 7, 2024InjuryDjo Llc9616086-2024-00098
- DECOMPRESSION OF CHOICEJun 27, 2024MalfunctionPivotal Health Solutions3007278668-2024-00003
- DECOMPRESSION OF CHOICEMay 17, 2024MalfunctionPivotal Health Solutions3007278668-2024-00002
- DECOMPRESSION OF CHOICEMay 16, 2024MalfunctionPivotal Health Solutions3007278668-2024-00001
- TRITON DTS PKG US STDApr 16, 2024MalfunctionDjo Llc9616086-2024-00025
Event type breakdown
Recalls
5 recall events for this product code
- Pivotal Health Solutions, Inc.Open, ClassifiedJul 10, 2024
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pound
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 had not been distributed yet.
Z-2326-2024 · View FDA record ↗ - Advanced Back Technologies, Inc.TerminatedJun 5, 2015
Extentrac Elite product brochure DCN: 13-001, 09-001 (Powered decompression table, for traction)
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
Z-1717-2015 · View FDA record ↗ - Advanced Back Technologies, Inc.TerminatedJun 5, 2015
Extentrac Elite User Manual DCN: 14-001 (Powered decompression table, for traction)
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
Z-1718-2015 · View FDA record ↗ - Spinetronics, LLCTerminatedApr 2, 2012
Removal of Literature/Brochures for Antalgic-Trak. "***What is Antalgic-Trak?***Articulating Non-Surgical Spinal Decompression****Antalgic-Trak By Spinetronics
On 08/11/2011 Spinetronics, LLC initiated a recall of Antalgic-Trak Product Brochures which contained language and/or claims that were not cleared under the original 510k, and represented a major change or modification in the intended use of the device.
Z-1360-2012 · View FDA record ↗ - Mettler Electronics CorpTerminatedJun 17, 2011
MTD 4000 - Mettler Traction Decompression System, Model: ME 4000
The recall was initiated because Mettler has confirmed the possible failure of internal mechanical component and software detection for potential failure regarding Electronics Traction Device - MTD4000. The firm are initiating the recall because component failure might result in patient injury. Use of the device should cease immediately.
Z-2580-2011 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Hill Laboratories
Frazer, PA, US
Djo, Llc
Carlsbad, CA, US
Dj Orthopedics De Mexico, S.a. De C.v.
TIJUANA Baja California, MX
Pivotal Health Solutions
Watertown, SD, US
Zmi Electronics Ltd.
KAOHSIUNG, TW
Excite Medical Of Tampa Bay Llc
Tampa, FL, US
Zimmer Medizinsysteme Gmbh
NEU-ULM Bavaria, DE
Enraf-nonius B.v.
ROTTERDAM Zuid-Holland, NL
Zober Industries, Inc.
Croydon, PA, US
North American Medical Corporation
Marietta, GA, US
Ito Co., Ltd.
Kawaguchi Saitama, JP
Mettler Electronics Corp.
ANAHEIM, CA, US
Everyway Medical Instruments Co., Ltd.
NEW TAIPEI CITY, TW
Hollywog, Llc
Chattanooga, TN, US
Ito Co., Ltd. Tsukuba Factory
Inashiki-Gun Ibaraki, JP
Universal Pain Technology Canada Inc.
PRINCE GEORGE British Columbia, CA
510(k) clearances
71 clearances for this product code
- Excite Medical of Tampa Bay, LLCJul 18, 2025
K243775 · True Non-Surgical Spinal Decompression System (DRX9000-SL)
- Excite Medical of Tampa Bay, LLCJun 18, 2025
K243366 · DRX9000C-SL Cervical Spinal Decompression System
- Ergo-Flex Technologies, LLCFeb 22, 2024
K214037 · Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
- Zimmer Medizinsysteme GmbHMay 16, 2023
K222912 · c1Trac
- Enraf-Nonius, B.V.Oct 16, 2015
K151640 · ELTRAC 471
- Hollywog, LLCAug 13, 2015
K150695 · Modpod
- Pivotal Health SolutionsSep 10, 2014
K131983 · ITRAC CERVICAL TRACTION SYSTEM
- Integrity Life SciencesFeb 6, 2014
K130249 · INTEGRITY SPINAL CARE SYSTEM 3.0