Search Results
Found 1 results
510(k) Data Aggregation
K Number
K050156Device Name
WHS-1000 WOUND HEALING SYSTEM
Manufacturer
Date Cleared
2005-06-17
(144 days)
Product Code
Regulation Number
878.5650Why did this record match?
Applicant Name (Manufacturer) :
IYIA TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy. The device is intended for the treatment of the following kinds of wounds: - skin ulcerations due to diabetes, venous stasis, and post surgical infections - gangrenous lesions, - decubitus ulcers . - amputations/infected stumps . - . skin grafts - . burns - frostbite ♥ Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.
Device Description
The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.
Ask a Question
Ask a specific question about this device
Page 1 of 1