(118 days)
The Compression Therapy Device is intended to be an easy to use portable by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation;
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
- · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Compression Therapy Device
Based on the provided text, the document is an FDA 510(k) clearance letter for a "Compression Therapy Device." This letter does not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be required to answer your request.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It discusses regulatory compliance, labeling, and other administrative aspects. It does not provide a technical report of device performance or the study design and results validating its functionality against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, you would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a comprehensive technical submission to the FDA.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).