FREEWAY NEBULIZER COMPRESSOR

Description of Device:

The Freeway Nebulizer Compressor 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 IEC 60601-1).

When the compressor is used in conjunction 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 Freeway Nebulizer Compressor system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

Intended Use:

The Freeway Nebulizer Compressor includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Technological Characteristics:

The Freeway Nebulizer Compressor 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 Freeway Nebulizer Compressor is substantially equivalent to the existing legally marketed predicate devices and that all of these devices will produce a similar aerosol treatment.

510(k) Number: K895592

Device Name：FREEWAY NEBULIZER COMPRESSOR

Manufacturer: HENGSHENG INDUSTRY CO., LIMITED