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510(k) Data Aggregation
K Number
K113236Device Name
FORYOU NPWT DEVICE
Manufacturer
Date Cleared
2013-02-12
(468 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
FORYOU MEDICAL ELECTRONICS CO, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris.
Device Description
Foryou NPWT NP32 Device is an AC-powered, portable suction pump with a back-up battery. The pump is used in combination with wound dressing kits, a bacteria filter, suction tubing, drainage tubing, and a disposable canister. Foryou NPWT NP32 Device is designed for hospital use only with specified wound dressing kits to deliver a recommended therapeutic range of -55mmHg of continuous or intermittent negative pressure wound therapy to the wound, which may promote wound healing through the removal of excess exudates, infectious material, and tissue debris by:
- preparing the wound bed for closure
- reducing edema
- promoting granulation tissue formation and perfusion
- removing exudate and infectious material
The wound dressing kits, bacteria filter, suction tubing, drainage tubing, and disposable carister are not included in the Forvou NPWT device package.
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