Search Results

UAM-8100, UAM-8100N is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

UAM-8100, UAM-8100N is a system to improve the blood circulation of patients and User can use it personally under their doctor's indication and guidance. UAM-8100, UAM-8100N is combined with leg and foot garments. The leg garment has four air chambers operated by a controller. The leg garment is compressed sequentially in order of foot, calf, and thigh, and then fresh air is injected inside the leg garment through holes

The provided document is a 510(k) premarket notification decision letter from the FDA for the "Air Relax/Compressible Limb Sleeve System Model No. UAM-8100, UAM-8100N." This type of document is a regulatory approval, not a clinical study report.

Therefore, the information required to answer your questions about acceptance criteria and a study proving device performance (tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in this document.

This document primarily focuses on demonstrating substantial equivalence to a predicate device (K130385) based on non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, and software verification/validation) and comparing design specifications. It does not detail clinical effectiveness studies with specific performance metrics or acceptance criteria for those metrics.

Ask a specific question about this device