The Devilbiss Model 4650 Compressor Nebulizer utilizean AC motor driven air compressor to provide a source of compressed air for operating ajet nebulizer. The system converts liquid medication into an aerosol form that can be inhaled by the patient.

Devilbiss Model 4650 Compressor Nebulizer provides mouthpiece mode and mask mode. Using our Nebulizer, you can easily nebulization whether you are sitting or lying down.

[You Deserve The Best] The Devilbiss Model 4650 Compressor Nebulizer equipped 3 masks are medical-grade PP material made. Face-fitting design to ensure a non-irritating, sensitive-free experience for children, adults, and elders.

[Exclusive Home Nebulization Design] Our Devilbiss Model 4650 Compressor Nebulizer equips anti-slip pads at the device’s bottom to enable shock absorption and noise reduction, lowering operational volume down to 52dB.

[More Cost-Effective & Great Comfort] Devilbiss Model 4650 Compressor Nebulizer medicine cup’s capacity is up to 7ml.

Device Description

The DeVilbiss Model 4650 Compressor Nebulizer is a small, piston-type air compressor.
sized to provide the proper flow and pressure sufficient to power jet (pneumatic)
nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and 1EC 60601-1)
When the compressor is used in coniunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 4650 compressor nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

Indications for Use

The DeVilbiss Model 4650 Compressor Nebulizer is an AC powered air compressor that provides a source of compressed air for home health care use. The product is used in conjunction with a jet (pneumatic) nebulizer to convert liquid medication into an aerosol form with particles smaller than $ microns diameter for inhalation into the patient's respiratory tract for the treatment of respiratory disorders.

The target population for this device consists of adult patients suffering from, but not limited to asthma, cystic fibrosis, and chronic obstructive pulmonary disease. Further，additional applications for aerosolized medication are constantly under investigation and this device may be deemed suitable for such applications as prescribed.

The intended environment for use of the product is in the patient's home on the order of a physician.

Technological Characteristics

The DeVilbiss Model 4650Compressor Nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer. All of the devices are tested and approved to recognized agency safety standards.

Testing performed on the aerosol output and particle size show that the new DeVilbiss Model 4650 Compressor Nebulizer is substantially equivalent to the existing legally marketed predicate devices and that all ofthese devices will produce a similar aerosol treatment.

510(k) Number: K931015

Device Name: DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER

Manufacturer: DeVilbiss Healthcare LLC