Search Results
Found 1 results
510(k) Data Aggregation
K Number
K132124Device Name
KLARITY VACUUM BAG, KLARITY MOLD CUSHION
Manufacturer
KLARITY MEDICAL PRODUCTS, LLC
Date Cleared
2013-11-01
(114 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
KLARITY MEDICAL PRODUCTS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate the most accurate treatment of tumors.
Patients are those that have been diagnosed and are undergoing treatment for cancerous turnors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.
Device Description
**Klarity Vacuum Cushions:** The Klarity Vacuum Cushions are similarly constructed with a polyurethane coated nylon material. The vacuum bags are filled with small polystyrene spheres. The Klarity Vacuum cushions are airtight and fitted with a self-closing valve for ease of use. When air is evacuated, the cushions contract to hold a rigid shape over the course of the radiation therapy treatment.
**Klarity Mold Cushions:** The cushion has an inner component of small polystyrene spheres. These are surrounded by a 1/16" layer of polycaprolactone thermoplastic that softens and is moldable at 150° F. The thermoplastic layer has a nylon stockinette material surrounding it, for patient comfort.
Ask a Question
Page 1 of 1