Foryou NPWT Dressing Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190119 FDA 510(k)
- FDA Product Code
- OMP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Foryou NPWT Dressing Kit is a Negative Pressure Wound Therapy (NPWT) device designed to promote wound healing by applying controlled negative pressure to the wound bed. It facilitates the removal of excess fluid, enhances blood flow, and reduces bacterial load, supporting granulation tissue formation in acute and chronic wounds.
This single-use kit is intended for use in clinical settings, including hospitals and outpatient care, and is supplied sterile. It includes components compatible with NPWT systems and adheres to regulatory standards such as FDA 510(k) clearance and MDR compliance. The kit is non-magnetic and suitable for use in non-MRI environments. Sizes and configurations are specified per clinical application, with storage requirements adhering to standard sterile supply protocols.
Frequently asked questions
What is the purpose of the Foryou NPWT Dressing Kit?
The Foryou NPWT Dressing Kit is designed to promote wound healing by applying controlled negative pressure to the wound bed, which helps remove excess fluid, enhances blood flow, and reduces bacterial load to support granulation tissue formation in acute and chronic wounds.
Is the Foryou NPWT Dressing Kit single-use or reusable?
The Foryou NPWT Dressing Kit is a single-use kit that is supplied sterile for use in clinical settings including hospitals and outpatient care.
What sizes and configurations are available for the Foryou NPWT Dressing Kit?
Sizes and configurations for the Foryou NPWT Dressing Kit are specified per clinical application, with components compatible with NPWT systems to meet various wound care needs.
What are the storage requirements for the Foryou NPWT Dressing Kit?
The Foryou NPWT Dressing Kit must be stored according to standard sterile supply protocols to maintain its integrity and sterility until use.
Is the Foryou NPWT Dressing Kit suitable for MRI environments?
The Foryou NPWT Dressing Kit is non-magnetic and is suitable for use in non-MRI environments, as it is not designed for MRI-compatible applications.
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. Sources consulted: Foryou NPWT: Negative Pressure Wound Therapy by 4L Health, Foryou NPWT: Negative Pressure Wound Therapy by 4L Health, NPWT System Manufacturer | Foryounpwt, Foryou NPWT: Negative Pressure Wound Therapy by 4L Health
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K190119 | Class II | Active |
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Manufacturer
- Manufacturer
- 4L Health Co., Ltd.
Sources (2)
- FDA 510(k) K190119 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026