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K Number
K214053
Device Name
Amputee Garment for use with Lympha Press Optimal Plus
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2022-04-14

(108 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · 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

Device Description

Amputee Garment for use with Lympha Press Optimal Plus

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "Amputee Garment for use with Lympha Press Optimal Plus." This document describes the device's regulatory clearance and its intended uses, but it does not contain any information about acceptance criteria, a specific study proving device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies (like MRMC or standalone AI performance studies).

Therefore, I cannot provide the requested information based on the input 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).