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510(k) Data Aggregation
K Number
K070457Device Name
SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
Manufacturer
SUN SCIENTIFIC LLC
Date Cleared
2007-05-16
(89 days)
Product Code
MHW
Regulation Number
880.5075Why did this record match?
Applicant Name (Manufacturer) :
SUN SCIENTIFIC LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To assist in the management of venous stasis ulcers by applying pressure.
Device Description
The device includes a Leg Compressor and a Pre-Filled Air Bladder (PFAB).
The PFAB does not apply pressure, but when it is used in conjunction with a compression bandage, it will exert local pressure (because of the air pocket). Compression bandages exert pressure, therefore the pre-filled air bladder will redistribute the pressure that the bandage would already by supplying.
Overall the device is meant to redistribute and apply pressure to the venous ulcer. It has been found over the years that compression bandages or stockings healed more venous leg ulcers than no compression.
If the venous ulcer is kept covered and clean with applied pressure the healing process is more effective. The concept behind this device is to keep the wound covered and apply pressure on the wound.
#### PFAB (Pre-Filled Air Bladder)
The PFAB is an oval shaped polyurethane pre-filled air bladder with four flanges. The tips of the flanges have medical adhesive, which adheres to the skin. The bottom of the PFAB has medical grade hydrophilic foam, which will cover the ulcer and is used to absorb the exudates.
The PFAB will be offered in three sizes (Small, Medium, and Large).
#### Leg Compressor
The leg compressor is used to hold the PBAB in place and apply additional pressure. The leg compressor contains an air chamber that is made of 2 layers of urethane film. The outer black fabric is Nylon. The leg compressor also has a self adjusting manometer attached to the outside to measure the pressure within the air bladder, which will be situated along the Great Saphenous Vein.
The manometer is used for reference only and is not meant to be used for accurate measurements of pressure.
The Leg Compressor includes a safety release valve to deflate the compressor. In addition, the manometer is color coded. As a precaution the user should not inflate the compressor in the red zone.
The pressure at the beginning of the red zone is approximately 30 mm Hg, which is similar to the pressure from a typical Umma Boot or compression bandage.
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