DRX 2000 Powered Traction Equipment
by Axiom Worldwide, Inc. 510(k)
Active
510(k) K010292
Overview
The DRX 2000 is a Powered Traction Equipment designed for physical medicine applications. It provides controlled mechanical traction to assist in spinal decompression and joint mobilization, aiding in the management of musculoskeletal conditions.
This device is supplied as a reusable medical instrument and is classified under 21 CFR Section 890.5900 as Class II. It is intended for use in clinical settings such as physical therapy or orthopedic rehabilitation, with no specific sterility requirements noted. The DRX 2000 holds an FDA 510(k) clearance (K010292) and is regulated under the Product Code ITH for traction equipment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK010292 | Date1 May 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Drx 2000
- 510(k) Number
- FDA Product Code
- ITH
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5900
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Other devices from Axiom Worldwide, Inc.
Questions
What clinical applications is the DRX 2000 primarily used for in physical medicine settings?
The DRX 2000 is designed for controlled mechanical traction to assist with spinal decompression and joint mobilization, helping manage musculoskeletal conditions. It is specifically intended for use in physical therapy or orthopedic rehabilitation to alleviate pain and improve mobility in patients with spinal or joint-related issues.
Is the DRX 2000 a single-use or reusable device, and what does that mean for maintenance?
The DRX 2000 is supplied as a reusable medical instrument, meaning it is built for repeated use across multiple patients. Since it is not sterile by default, facilities must follow proper cleaning, disinfection, and maintenance protocols to ensure safety and functionality between uses, as outlined in the manufacturer’s instructions.
How is the DRX 2000 regulated, and what does its FDA clearance indicate about its safety and effectiveness?
The DRX 2000 holds an FDA 510(k) clearance (K010292), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the FDA has reviewed its design and determined it meets applicable safety and performance standards for powered traction equipment under Product Code ITH, classified under 21 CFR 890.5900 as Class II.
What types of facilities or departments would typically use the DRX 2000, and why?
The DRX 2000 is intended for use in clinical settings specializing in physical medicine, such as physical therapy clinics, orthopedic rehabilitation centers, or sports medicine facilities. Its design supports controlled traction for spinal decompression and joint mobilization, making it ideal for treating musculoskeletal conditions where mechanical assistance aids recovery or pain management.
Does the DRX 2000 come with specific storage or handling instructions, and why are those important?
While the provided data does not detail specific storage instructions, as a reusable medical device, the DRX 2000 should be stored in a clean, dry environment to prevent damage or contamination. Proper handling is critical because it ensures the device remains functional for repeated use and maintains hygiene standards, reducing the risk of cross-contamination or mechanical failure during therapy sessions.