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510(k) Data Aggregation
K Number
K190119Device Name
Foryou NPWT Dressing Kit
Manufacturer
Date Cleared
2019-11-01
(281 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
4L Health Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Foryou NPWT Dressing Kit is intended to be used with Foryou NPWT Device to manage wounds through removal of fluids, and the NPWT system is indicated for patients who would benefit from a suction device, particularly as it may promote wound healing by removal of fluids, excess exudate, infectious material, and tissue debris. Foryou NPWT Dressing Kit is indicated for use in patients with the following wounds: traumatic, dehisced wounds, partial-thickness burns, chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers, acute wounds, flaps and grafts.
Device Description
Foryou NPWT Dressing Kit is the wound dressing kit to be used with Foryou NPWT Device for negative pressure wound therapy. It consists of three key components: the foam dressing, the tube unit, and the transparent film. The components are kitted into medical pouch and sterilized, or individually packaged and sterilized. Foryou NPWT Dressing Kit is single-use and sterile. It is available in different sizes: small, medium, large and extra large. The foam dressing should not be used for more than 24 hours and should be replaced with other dressings compatible with Foryou NPWT pump as stated in the Foryou NPWT pump labeling.
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