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The Devon24D deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

This device can be used in the home or clinical settings to:

• Aid in the prevention of DVT

• Enhance blood circulation

• Diminish post-operative pain and swelling

• Reduce wound healing time

• Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

• As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

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I apologize, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Devon 24D Deep Vein Thrombosis Prevention Therapy System, confirming its substantial equivalence to previously marketed devices and outlining its indications for use. It does not include details about specific performance metrics, test sets, or ground truth establishment.

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