HAND-HELD NEBULIZER

Description of Device:

The HAND-HELD Nebulizer are vibrating mesh nebulizers that use low frequency vibration to create aerosol and deliver aerosolized medication to the lower respiratory tract by using a vibrating mesh to create aerosol and provide fine particles to the patient's lungs. The mesh plate has holes to create low velocity aerosol.

The HAND-HELD Nebulizer are portable size, curvaceous body design that is convenient to hold, Which are battery powered. The medication container capacity is 8ml maximum.

For devices, they are pushed by certain circuit frequency vibration to make piezoelectric ceramic vibrate harmony that caused high speed vibration of metal mesh. And themedicine liquid will be quickly popped through micro mesh hole of metal mesh plate to be countless micro atomizing particles. This will be further transferred by inhalation treatment using masks or mouthpieces to patients' respiratory system.

Intended Use:

The HAND-HELD Nebulizer is an over-the-counter device designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (>4 years of age), defined by the prescribed medication, and adult patients in the home, hospital and sub-acute care settings. It is not intended for use with Pentamidine.

Technological Characteristics:

The HAND-HELD Nebulizer vibrating mesh nebulizerincorporated a piezoelectrictransducer that vibrates at afrequency (115kHz) when electricalcurrent is applied. The vibration ofthe transducer is transmitted to ametal allow mesh vapor disk thatcontains approximately 5,000 holes that are in contact with the liquid tobe nebulized. An electrical chargeapplied to the piezoelectrictransducer, in turn, leads tovibration (inward and outwardmovement of the mesh vapor disk),passing the liquid through the holesto form an aerosol. HAND-HELD Nebulizer is battery operated.

510(k) Number: K940257

Device Name: HAND-HELD NEBULIZER

Manufacturer: HONG KONG LANLI TECHNOLOGY CO., LIMITED