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510(k) Data Aggregation
K Number
K101224Device Name
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
Manufacturer
Date Cleared
2010-12-03
(214 days)
Product Code
Regulation Number
880.5780Why did this record match?
Applicant Name (Manufacturer) :
GRIFFITHS AND NIELSEN LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SaphenaMEDICAL Anti-Embolism Stockings are intended to:
- Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs.
- Help to prevent Deep Vein Thrombosis (DVT) and, edema and leg discomfort in . individuals subjected to immobility.
Device Description
SaphenaMEDICAL Anti-Embolism Stockings are ready-to-wear for post-operative/ surgical, reclining or bed-confined patients, to help prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and lycra which is used in the predicate devices.
The SaphenaMEDICAL Anti-Embolism Stockings provide controlled, uniform graduated conpression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 18 mmHg (based on average ankle size) then gradually decreases up to the proximal end. (14mmHg at the mid-calf and 8mmHg at the upper thigh)
Compression for the SaphenaMEDICAL Anti-Embolism Stockings, as well as all the predicate devices, is provided by lycra that acts circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema.
The Anti-Embolism Stockings are not made with natural rubber latex.
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