Products – Fainteer Limited

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Products

Nebulizer Mask for Adult

Sale

Nebulizer Mask for Adult

Regular price $200.00 Sale price $100.00

Sale price $100.00 Regular price $200.00
Nebulizer Mask for Child

Sale

Nebulizer Mask for Child

Regular price $200.00 Sale price $100.00

Sale price $100.00 Regular price $200.00
Nebulizer Mouthpiece

Sale

Nebulizer Mouthpiece

Regular price $200.00 Sale price $100.00

Sale price $100.00 Regular price $200.00
Ultrasonic Nebulizer, Model NE-520 - Portable Nebulizer, Nebulizers, Rechargeable Nebulizer Machine for Adults and Kids

Sale

Ultrasonic Nebulizer, Model NE-520 - Portable Nebulizer, Nebulizers, Rechargeable Nebulizer Machine for Adults and Kids

Regular price $500.00 Sale price $250.00

Sale price $250.00 Regular price $500.00
Ultrasonic Nebulizer, Model NE-520, Portable Nebulizer Machine with Mask, Mouthpiece and Accessories - Rechargeable Nebulizer for Home Use, Take-Along Nebulizer for Kids

Ultrasonic Nebulizer, Model NE-520, Portable Nebulizer Machine with Mask, Mouthpiece and Accessories - Rechargeable Nebulizer for Home Use, Take-Along Nebulizer for Kids

$200.00

$200.00

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