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510(k) Data Aggregation
K Number
K213906Device Name
extriCARE 1000 Negative Pressure Wound Therapy System
Manufacturer
Date Cleared
2023-03-08
(449 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
Alleva Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed.
The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include:
- Chronic wounds
- Acute wounds
- · Traumatic wounds
- · Subacute and dehisced wounds
- · Partial-thickness burns
- · Ulcer wounds (such as diabetic or pressure)
- · Flaps and grafts
- · Closed surgical incisions
The extriCARE 1000 NPWT System is intended for use in healthcare facilities.
Device Description
The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) system consists of a portable, battery-powered pump unit intended to generate vacuum pressure to remove low to moderate level of wound exudates, infectious material, and tissue debris from the wound bed. Three preset vacuum pressures can be selected by the user - 80, 100, and 125mmHg. The extriCARE 1000 is packaged and provided with the following components:
- 1. extriCARE 1000 Negative Pressure Wound Therapy Pump
- 2. extriCARE 1000 50cc Collection Canister
The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) Pump accessory that is included in this 510(k) applications and will be commercialized separately is the extriCARE 1000 50cc Collection Canister (additional cannister replacements).
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