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745-M (Magnum)

by Tri W-G, Inc.

510(k) K922980

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK922980 Date13 Jul 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.