Description
Description of Device
The Nebulizer No. M-175 is a vibrating mesh-type aerosol delivery system intended to transform liquid medication into a fine mist for inhalation therapy. It operates via a piezoelectric ceramic actuator (PZT), which vibrates a polymer mesh containing multiple micro-apertures. These vibrations mechanically disrupt the surface tension of the liquid medication, pushing it through the mesh to produce a fine aerosol. The nebulizer includes a medicine cup (with a 7 ml capacity), an integrated mouthpiece, and a main unit powered by an AC 110V adaptor. The device features a one-button on/off operation and is intended for single-patient, multi-use applications. The medicine cup is cleanable and disinfectable through boiling.
Intended Use
The Nebulizer No. M-175 is intended to aerosolize liquid medications for inhalation by patients. It is used to deliver medication in fine mist form to relieve various respiratory symptoms. The device is suitable for use by children over 4 years old and adults in home and healthcare environments. It is for over-the-counter use.
Technological Characteristics
The M-175 nebulizer uses vibrating mesh technology to convert liquid medication into aerosol. Its core mechanism is driven by a piezoelectric ceramic actuator that transmits vibration to a mesh plate with micro-apertures. This vibration (at a frequency of approximately 60 kHz) generates aerosol particles without the need for compressed air. The system is software-controlled via internal firmware to regulate frequency and maintain a nebulization rate greater than 0.2 ml/min, with power consumption under 1.5 W. Compared to the predicate device (Omron NE-U22, K062263), the M-175 demonstrates equivalent technological characteristics, including aerosol generation method, single-patient multi-use design, cleanable components, and biocompatibility per ISO 10993 testing.
510(k) Number: K790924
Manufacturer: Fainteer Limited
Device Name: NEBULIZER NO. M-175
Classification Name: Nebulizer (Direct Patient Interface)
Product Code: CAF
Device Class: 2
Regulation Number: 868.5630
Medical Specialty: Anesthesiology
Registered Establishment Name: Fainteer Limited
Registered Establishment Number: 3031506335
Premarket Submission Number: K790924
Owner/Operator: Fainteer Limited
Owner/Operator Number: 10090514
Establishment Operations: Manufacturer; Repackager/Relabeler