Search Results

Increase of Local Blood Circulation.

Treatment of Range of Motion when combined with exercise.

Treatment for minor pain and stiffness of non-rheumatoid arthritis.

The Fluidotherapy type devices describe a process where ground cellulose is held in animated suspension through a screen filter (often called the Fluidizing Bed) and held captive by a housing and flexible velcro tightening sleeves.

This process then allows for a hand, wrist, foot, ankle, and on larger units, the lower leg to be immersed in the heated cellulose.

The now fluidized cellulose gently and warmly massages the extremity resulting in improved blood circulation, wound healing, comfort, etc.

Thermo-Electric's Thermo-Therapy devices have identical technology characteristics to that of Fluidotherapy.

The provided text from K0111768 is a 510(k) summary and associated FDA correspondence for a device called "Thermo-Therapy - Models TT-101, TT-201, and TT-202". This document does not contain information about acceptance criteria, device performance studies, or the methodologies for such studies.

Specifically:

• It states that the Thermo-Therapy products are "virtually identical" or have "identical technology characteristics" to existing Fluidotherapy models (K871802 and K896817).
• The submission is for demonstrating substantial equivalence to these predicate devices.
• The FDA letter confirms the finding of "substantial equivalence" based on the provided information.

Therefore, I cannot provide the requested information as it is not present in the given text. A 510(k) summary typically focuses on demonstrating equivalence to a predicate device, rather than providing detailed study results and acceptance criteria for de novo performance.

Ask a specific question about this device

Ask a specific question about this device