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510(k) Data Aggregation
K Number
K011768Device Name
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202
Manufacturer
THERMO-ELECTRIC CO.
Date Cleared
2001-08-03
(57 days)
Product Code
LSB
Regulation Number
890.5100Why did this record match?
Applicant Name (Manufacturer) :
THERMO-ELECTRIC CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Increase of Local Blood Circulation.
Treatment of Range of Motion when combined with exercise.
Treatment for minor pain and stiffness of non-rheumatoid arthritis.
Device Description
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.
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