PBS MODEL 701A COMPRESSION THERAPY DEVICE

• K Number: K060220
• Device Name: PBS MODEL 701A COMPRESSION THERAPY DEVICE
• Manufacturer: MEGO AFEK
• Date Cleared: 2006-02-09 ( 10 days)
• Product Code: JOW
• Regulation Number: 870.5800
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

Treatment of Venous disorders and Dysfunction of the "Muscle Pump"

Device Description

PBS (Petit Basic System) Model 701 A Compression Therapy Device

AI/ML Overview

This document does not contain the information required to answer your request. It is a 510(k) premarket notification letter from the FDA to Mego Afek Ltd. regarding their PBS Model 701A Compression Therapy Device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details of any study (sample sizes, data provenance, ground truth establishment, expert information, adjudication methods) used to prove the device meets acceptance criteria.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document primarily states that the FDA has reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices for the stated indications for use, thereby permitting the device to proceed to market. It outlines regulatory requirements that the manufacturer must comply with.

Regulation Number and Section

§ 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).