hcmed-inno.comAdheResp Smart Breath-actuated Mesh Nebulizer
Hcmed Innovations Co., Ltd.
HCMED INNOVATIONS CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016750005 | 3016750005 | HCMED INNOVATIONS CO., LTD. | 1 | N | 2026-01-01 | 2F., No.166, Jiankang Rd. Zhonghe Dist. New Taipei City TW 23585 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 04719873130030 | Pulmogine - The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, 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. | +886227326596 | info@hcmed-inno.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 297099 | 1032710648 | K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | CAF | 2025-06-20 |
| 297099 | 2069584158 | K202171 | Pulmogine Vibrating Mesh Nebulizer | CAF | 2021-07-01 |
| 297099 | 1828083586 | ||||
| 297099 | 1979378347 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CAF | 2 | 2025-06-20 |
PMN#
Pulmogine Vibrating Mesh Nebulizer
HCMed Innovations Co., Ltd.
GUDID#
Aerogen®Go - The Aerogen®Go Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Aerogen®Go 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 Aerogen®Go 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.
2024-08-20
Pulmogine - The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, 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.
2022-11-30
AdheResp - 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.
2026-01-29
Aerogen® Go - 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.
2026-01-28
Aerogen® Go - The Aerogen Go 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. This AC adaptor is in the sales package.
2026-01-28
Aerogen® Go - The Aerogen Go 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. This AC adaptor is for individual sale.
2026-01-28
Aerogen® Go - The Aerogen®Go Vibrating Mesh Nebulizer is a small, handheld, internally powered general-purpose nebulizer which utilizes vibrating mesh technology to generate aerosol. The Aerogen®Go 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 Aerogen®Go 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. In the package also includes masks with adult mask, paediatric mask and mouthpiece as the convenience kit.
2026-01-22
Pulmogine® - The Pulmogine Vibrating Mesh Nebulizer is a small, handheld, 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. In this package also includes masks with adult mask, paediatric mask and mouthpiece as the convenience kit.
2026-01-22