(89 days)
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Lympha Press Optimal Plus Model 912
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical device called "Lympha Press Optimal Plus." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way you've requested.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and lists the indications for use. It's a regulatory approval document, not a scientific study report.
Therefore, I cannot fulfill your request for the specific details of acceptance criteria and study information as they are not present in the provided text.
§ 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).