745-M (Magnum)
510(k) K922980
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922980 | Date13 Jul 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JFB
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5880
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The 745-M (Magnum) is a multi-function table for physical therapy, classified as a Class II device under FDA regulations. It is designed to support various therapeutic interventions in physical medicine, including adjustments for patient positioning and treatment applications.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as physical therapy clinics or rehabilitation centers. It adheres to FDA clearance (510(k) K922980) and is regulated under the Physical Medicine advisory committee. No specific sterility or MRI safety information is provided in the available data.
Other devices from Tri W-G, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of therapeutic interventions can the 745-M (Magnum) multi-function table support in physical therapy settings?
The 745-M (Magnum) is designed to support a variety of physical therapy interventions by providing adjustable patient positioning and treatment applications. Its multi-function design allows for flexibility in clinical settings like physical therapy clinics or rehabilitation centers, making it suitable for diverse rehabilitation needs.
Is the 745-M (Magnum) intended for single-use or reusable applications in clinical environments?
The 745-M (Magnum) is explicitly supplied as a reusable medical instrument, meaning it is meant to be cleaned, disinfected, and reused across multiple patients in clinical settings such as physical therapy clinics or rehabilitation centers.
How is the regulatory status of the 745-M (Magnum) defined by the FDA, and what does this mean for its use?
The 745-M (Magnum) holds FDA 510(k) clearance (K922980) under the Physical Medicine advisory committee, classified as a Class II device. This clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, meaning it meets FDA safety and effectiveness standards for use in physical therapy applications as described in the device’s intended purpose.
What storage or handling considerations should be noted for the 745-M (Magnum) table?
While the provided data does not specify sterility requirements or MRI safety, the 745-M (Magnum) is a reusable device intended for clinical use. Proper cleaning, disinfection, and maintenance protocols must be followed to ensure hygiene and longevity. If used in environments with MRI equipment, additional precautions (e.g., non-ferromagnetic materials) should be verified independently, as this information is not detailed in the available data.