Search Results

The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:

The CMP-001 (Compression Plus) is intended for:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
• Optional localized thermal therapy (hot or cold) for post traumatic and post surgical . medical and/or surgical conditions
• Aids the blood flow back to the heart .
• Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

The CMP-002 (DVTmax) is intended for:

• Treatment of disorders associated with vascular or lymphatic insufficiency such as ● Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
• Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains
• Optional localized thermal therapy (hot or cold) for post traumatic and post surgical ● medical and/or surgical conditions
• Decrease the risk of deep venous thrombosis (DVT) .
• Aids the blood flow back to the heart, .
• Treats and assists healing of cutaneous ulceration (wounds), reduce would healing ● time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Compression System - Models CMP-001 and CMP-002" manufactured by Novitas Medical, LLC. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter explicitly states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means the device's safety and effectiveness are considered comparable to existing devices, and a new study proving specific performance metrics against acceptance criteria is generally not required for 510(k) clearance.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria.

Ask a specific question about this device