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510(k) Data Aggregation
K Number
K080966Device Name
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
Manufacturer
Date Cleared
2008-08-06
(124 days)
Product Code
Regulation Number
878.5650Why did this record match?
Applicant Name (Manufacturer) :
AOTI LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AOTI Hyper-Box Topical Wound Oxygen System is intended to be used for the treatment of open acute or chronic wounds, such as;
- skin ulcerations due to diabetes, venous stasis, post surgical infections o and gangrenous lesions
- decubitus ulcers O
- amputations/infected stumps 0
- skin grafts O
- burns O
- frostbite o
Device Description
The Hyper-Box Topical Wound Oxygen System is a non-invasive device intended to allow the application of topical oxygen at slightly above atmospheric (hyperbaric) pressure to wounds and ulcers of the extremities.
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