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The Capifio 5001 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system. prescribed by a physician, and used to help prevent the onset of Deep Vein Thrombosis (DVT) in patients by stimulating blood flow in the extremities (through the stimulation of muscle contractions).

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

• Assist and aid in the prevention of Deep Vein Thrombosis (DVT).
• As a prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be stationary for long periods of time.
• To increase blood circulation in the lower limbs.
• Help reduce postoperative swelling and pain.
• Cut down on wound healing time.
• Capiflo can assist in the treatment of:
  • Chronic venous insufficiency
  • The reduction of edema in lower limbs
  • Venous stasis ulcers
  • Arterial leg ulcers
  • Diabetic leg ulcers
  • Stasis dermatitis

Not Found

I apologize, but the provided text is a 510(k) clearance letter for the Capiflo 5001 device, which is a Compressible Limb Sleeve. This document does not contain information about the acceptance criteria for a study, reported device performance, sample sizes, ground truth establishment, or any details about a study conducted to prove the device meets acceptance criteria.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the Capiflo 5001, which are related to preventing Deep Vein Thrombosis (DVT), increasing blood circulation, reducing swelling and pain, and assisting in the treatment of various venous and arterial conditions.

Therefore, I cannot provide the requested information based on the given text.

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