Total Work Integrator, Model #940-110

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922603 ↗

FDA Product Code

ISD

Device Class

Class II

Regulation

21 CFR Part 890.5360

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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See all devices from Biodan Medical Systems, Ltd. →

• What is the Total Work Integrator Model 940-110 used for?

  The Total Work Integrator, Model 940-110, is designed specifically for assessing and quantifying a patient’s physical work capacity and exercise performance. It is intended for use in clinical or rehabilitative settings, such as physical therapy, to monitor and integrate metrics related to patient exertion during therapeutic exercise regimens. This helps clinicians evaluate progress, tailor rehabilitation programs, and optimize recovery outcomes.

• Is the Total Work Integrator Model 940-110 reusable or single-use?

  The Total Work Integrator, Model 940-110, is supplied as a reusable medical instrument. It is not intended for single-use applications and is meant to be used repeatedly in clinical or physical therapy environments. Reusability is supported by its design and regulatory classification as a reusable Class II device.

• Does the Total Work Integrator Model 940-110 require sterilization?

  The device does not require sterilization as it is intended for use in non-sterile conditions. The regulatory data does not specify any sterility requirements, and it is classified as a reusable medical instrument for clinical or rehabilitative use. Standard cleaning and maintenance procedures should be followed to ensure proper hygiene and functionality.

• What regulatory approval does the Total Work Integrator Model 940-110 hold?

  The Total Work Integrator, Model 940-110, is authorized under the FDA 510(k) clearance process with the clearance number K922603. It is classified as a Class II device under the regulation number 890.5360, which pertains to exercisers, measuring. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.

• Can the Total Work Integrator Model 940-110 be used in MRI environments?

  No, the Total Work Integrator, Model 940-110, is not intended for use in MRI environments. The regulatory data explicitly states that it does not require MRI safety considerations, meaning it is not designed or tested for compatibility with magnetic resonance imaging systems. Always ensure the device is used in appropriate non-MRI settings.