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Foshan Care Medical Nebulizer Model KYWH2001

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K101552

by Foshan Care Medical Technology Co., Ltd.

Identifiers

510(k) Number
K101552 FDA 510(k)
FDA Product Code
CAF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5630 FDA 510(k)
Regulation Number
868.5630 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Foshan Care Medical Nebulizer Model KYWH2001 is a portable, battery-powered device classified as a Compressed Gas Nebulizer (FDA Product Code CAF). It converts liquid medication into a fine mist for inhalation therapy, delivering precise doses of aerosolized drugs to the respiratory tract. Designed for use in clinical and home settings, it is intended for patients requiring nebulized treatments, such as those with asthma, COPD, or cystic fibrosis.

This device is supplied as a single-use or reusable system, depending on the attached components, and is intended for use in non-MRI environments. It operates on a 9V battery or AC power supply and includes a mask or mouthpiece for patient administration. Authorized under FDA 510(k) clearance (K101552) and compliant with the Medical Device Directive (MDD) and Medical Device Regulation (MDR), it is intended for respiratory therapy applications in controlled clinical settings.

Frequently asked questions

What types of respiratory conditions is this nebulizer designed to treat, and how does it work?

The Foshan Care Medical Nebulizer Model KYWH2001 is designed for patients requiring nebulized treatments, such as those with asthma, COPD (chronic obstructive pulmonary disease), or cystic fibrosis. It converts liquid medication into a fine mist through aerosolization, allowing precise delivery of aerosolized drugs directly to the respiratory tract for effective inhalation therapy.

Can this nebulizer be used at home, and what power sources does it support?

Yes, the KYWH2001 is designed for use in both clinical and home settings. It operates on a 9V battery for portability or can be powered via an AC power supply, making it flexible for different environments.

Is this device single-use or reusable, and what components are included for patient administration?

The KYWH2001 can be used with either single-use or reusable components, depending on the attached parts. It includes a mask or mouthpiece for patient administration, allowing for versatile delivery options.

What regulatory approvals does this nebulizer hold, and how does that affect its use?

The KYWH2001 holds FDA 510(k) clearance (K101552), indicating it is deemed substantially equivalent to a legally marketed device, and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means it is authorized for respiratory therapy applications in controlled clinical settings and adheres to strict safety and performance standards.

Are there any restrictions on where this nebulizer can be used, such as MRI environments?

The KYWH2001 is explicitly intended for use in non-MRI environments. Since it contains electronic and battery components, it should not be used in areas with magnetic resonance imaging due to potential interference or safety risks.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Foshan Care Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K101552 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026