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The Devon 24R 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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The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System."

This document focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.

It does not contain any information about the acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies (like MRMC studies) related to the device's efficacy or accuracy.

Therefore, I cannot fulfill your request for the information about acceptance criteria and the study proving the device meets those criteria based solely on the provided text. The document is administrative and does not detail performance testing results.

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