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510(k) Data Aggregation
K Number
K090681Device Name
TANSCU O2
Manufacturer
Date Cleared
2009-08-12
(149 days)
Product Code
Regulation Number
878.5650Why did this record match?
Applicant Name (Manufacturer) :
ELECTROCHEMICAL OXYGEN CONCEPTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TransCu O2 low dose tissue oxygenation system is intended for use with wound dressings to treat the following: Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions Pressure ulcers Infected residual limbs Skin grafts Burns Frostbite
Device Description
TransCu O2 is a low dose tissue oxygenation system for the treatment of wounds such as venous leg ulcers, diabetic foot ulcers and pressure ulcers. TransCu O2 is intended for use with wound dressings. TransCu O2 consists of a handheld electrochemical oxygen concentrator, an oxygen delivery extension set and a wound site oxygen delivery cannula. The TransCu O2 device incorporates enhanced fuel cell chemistry, utilizing a Proton Exchange Membrane to electrochemically generate the low dose pure oxygen. The battery operated device is lightweight, portable and can be worn discretely, functioning in remote communication with the wound site through long microbore tubing. TransCu O2 extracts oxygen from room air; concentrates the oxygen through the PEM; and then creates an oxygen rich environment by increasing the available oxygen at the wound site under the dressing.
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