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510(k) Data Aggregation
K Number
K250583Device Name
AdheResp Smart Breath-actuated Mesh Nebulizer
Manufacturer
HCmed Innovations Co., Ltd.
Date Cleared
2025-06-20
(113 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
HCmed Innovations Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AdheResp Smart Breath-actuated Mesh Nebulizer is a system to aerosolize liquid medications for inhalation for patients ranging from pediatrics equal to or greater than 5 years old to adults who can coordinate breathing.
The environment of use are Hospital/institutional settings, home care use, schools, and long-term care facilities.
Device Description
The AdheResp Smart Breath-actuated Mesh Nebulizer consists of a main unit, medication reservoir, mouthpiece, key tag and charging cable, or power adapter. The medication reservoir could be further separated into a medication container and an aerosol chamber.
Principle of Operation: There are two key features in the AdheResp Smart Breath-actuated Mesh Nebulizer, which are vibrating mesh nebulization and breath-actuation functions. The AdheResp Smart Breath-actuated Mesh Nebulizer is an active mesh nebulizer. Active mesh nebulizers operate by electrically activating a piezoelectric (PZT) ceramic element that rapidly contracts and expands when applied a voltage to it. The vibrations of the PZT are transmitted to the mesh membrane, which is in contact with the liquid medication loaded in the medication container. This vibration pushes the liquid or suspension through the fine conical holes of the mesh, forming aerosol droplets for the user to inhale.
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K Number
K202171Device Name
Pulmogine Vibrating Mesh Nebulizer
Manufacturer
HCMed Innovations Co., Ltd.
Date Cleared
2021-07-01
(332 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
HCMed Innovations Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pulmogine® Vibrating Mesh Nebulizer is a system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital / institutional settings, home care use, schools, and long-term care facilities.
Device Description
The Pulmogine® Vibrating Mesh Nebulizer, whose dimensions are 74 mm (L) x 46 mm (W) x 96 mm (H), is a small, dumbbell-shaped, handheld, and internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Pulmogine® Vibrating Mesh Nebulizer is designed for a single patient, multiple uses, and mainly composed of a Main Unit and a Medication Reservoir.
The Main Unit contains the control circuitry and the firmware to control the vibrating mesh module in the Medication Reservoir and is powered by 2 AA alkaline batteries or an AC adaptor.
The Medication Reservoir contains the nebulizing module (mesh) where the liquid medication will be turned into aerosols. The prescribed medication is added into the reservoir with ten (10) ml of medication capacity, nebulized, and inhaled through the aerosol port.
The Pulmogine® Vibrating Mesh Nebulizer generates aerosol from liquid medication during turning on through pressing ON/OFF button and turning off when pressing ON/OFF button again, auto-turn off when no liquid detected, or 10-minute session completed. There are different LED lights to monitor the status and operating condition of the nebulizer: green indicates power on and normally working, yellow flash indicates low power caution, and constant yellow indicates shut-off due to too low power.
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