Audeal Smart Digital Display Nebulizer Machine for Adults and Kids, HEART NEBULIZER for Home Use
FDA 510(k) Reference
FDA 510(k) Reference
Brand: Audeal
Commercial Model: D77
Device Name: HEART NEBULIZER
510(k): K923596
Status: OTC / Non-Prescription
Indications for Use
Indications for Use
The HEART NEBULIZER is an over-the-counter (OTC), non-prescription, AC-powered compressor nebulizer intended for home use to aerosolize liquid medication for inhalation through a mouthpiece or mask by adults and children under adult supervision.
Smart Digital Display Nebulizer
Smart Digital Display Nebulizer
Smart Digital Display Nebulizer - Features a timing function and LED digital display for easy operation. Three timing options are available: 10 min, 20 min, and 30 min.
Portable, Compact, Heat Dissipation
Portable, Compact, Heat Dissipation
Portable, Compact, Heat Dissipation - Weighs about 2.8 lb and features a heat dissipation design for stable operation. Suitable for use beside your bed or on a desktop.
Complete Accessories
Complete Accessories
Complete Accessories - Includes an adult mask, child mask, air filter, air tube, nebulizer cup, mouthpiece, and user manual for daily use.
Quiet Compressor Nebulizer
Quiet Compressor Nebulizer
Quiet Compressor Nebulizer - The bottom of the nebulizer is equipped with shock-absorbing foot pads to help reduce vibration and noise during use.
easy-to-use
easy-to-use
Audeal is committed to providing practical and easy-to-use nebulizer products for daily home use.
Couldn't load pickup availability
50 in stock
Product Identification
Retail Brand: Audeal | Commercial Model: D77 | Device Name: HEART NEBULIZER | OTC Non-Prescription Nebulizer for Home Use
This product is sold under the Audeal retail brand with Commercial Model: D77. The marketed device corresponds to the FDA-cleared device name HEART NEBULIZER under 510(k) K923596 . Supporting commercial authorization and transaction documents are maintained for supply chain verification.
Product Specifications
Regulatory Product Identification
510(k) Number:K923596
Device Name: HEART NEBULIZER
Original 510(k) Applicant: Vortran Medical Technology 1, Inc.
Registered Establishment Name: PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
Proprietary Name: HEART Nebulizer
Classification Name:NEBULIZER (DIRECT PATIENT INTERFACE)
Product Code:CAF
Device Class:2
Regulation Number:868.5630
Medical Specialty:Anesthesiology
Registered Establishment Name:PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.
Registered Establishment Number:8030673
Premarket Submission Number:K923596
Owner/Operator:SunMed Group Holdings, LLC dba AirLife
Owner/Operator Number:10044795
Establishment Operations:Contract Manufacturer
Package Contents
Compressor Unit, Nebulizer Cup, Adult Mask, Child Mask, Mouthpiece, Air Filter, Air Tube, User Manual
Product Identification
Brand: Audeal
Device Name: HEART NEBULIZER
Technology: AC-powered compressor nebulizer
Environment of Use: Home use
Prescription Status: OTC / Non-Prescription
Distributor Information
Distributed by：Yunnan Huida Cloud Information Technology Co., Ltd.
Address: Room 905, Building 8, Phase II, Luosiwan International Trade City Community Committee, Yiliu Subdistrict Office, Guandu District, Kunming Area, China (Yunnan) Pilot Free Trade Zone, CN 650217
Tel: 15592455003
Email: HWY18987150992@outlook.com