Device Description
The ULTRASONIC NEBULIZER, MODEL NE-520 is small, handheld internally powered general purpose nebulizer which utilizes ultrasound vibrating mesh technology to generate aerosol. The ULTRASONIC NEBULIZER provides a vapor mist of medicine that has much smaller particles and can travel much deeper into the patient's lungs, resultingin much faster relief, The ultrasonic nebulizer is mad up of main unit, medicine cup, adult mask, kid mask and mouth piece, The shell of nebulizer battery cove and spray nozzle are made of ABS, the button decoration ring is silica gel, the medicine cup and button are made by PC, the mask is made of PVC, the mouth piece is made of Pp and the nebulizer piece is stainless steel.
Indications for Use
The ULTRASONIC NEBULIZER is an Over the Counter device intended for aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4years of age）and adult patients in the home, hospital and sub-acute care settings.
Principle of Operation / Technology
The proposed devices are vibrating mesh nebulizers that use low frequency vibration to create aerosol deliver aerosolized medication to the lower respiratory tract by using avibrating mesh to create aerosol provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.
510(k) Number:K002153
Device Name: ULTRASONIC NEBULIZER, MODEL NE-520
Manufacturer:Fainteer Limited
Device Name: ULTRASONIC NEBULIZER, MODEL NE-520
Classification Name: NEBULIZER (DIRECT PATIENT INTERFACE)
Product Code: CAF
Regulation Number: 868.5630
Device Class: 2
Medical Specialty: Anesthesiology
Registered Establishment Name: Fainteer Limited
Registered Establishment Number: 3031506335
Premarket Submission Number: K002153
Owner/Operator: Fainteer Limited
Owner/Operator Number: 10090514
Establishment Operations: Manufacturer; Repackager/Relabeler