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K Number
K140642
Device Name
PCD 737A
Manufacturer
MEGO AFEK AC LTD
Date Cleared
2014-06-10

(90 days)

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

PCD 737A 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
  • Reducing wound healing time
  • Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
  • Reduction of pain and swelling after injury and surgery
  • Enhancement of venous circulation
  • Prevention of venous stasis
  • Assistance in healing of cutaneous ulcers
  • Reduction of compartmental pressures
    The device is intended for hospital, home, and clinic use.
Device Description

Not Found

AI/ML Overview

I am sorry, but after reviewing the provided document, I was unable to find the acceptance criteria for a medical device and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PCD 737A device, which is a compressible limb sleeve. It mainly details the regulatory approval process, lists the indications for use, and includes standard FDA disclaimers and contact information.

There is no information regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample size used for a test set, data provenance, or details of a study.
  • Number or qualifications of experts used to establish ground truth.
  • Adjudication methods.
  • Results of a multi-reader multi-case comparative effectiveness study or any effect sizes.
  • Results of a standalone algorithm performance study.
  • Type of ground truth used.
  • Sample size for a training set or how its ground truth was established.

This document confirms the device's substantial equivalence to a predicate device, which is a regulatory assessment, not a detailed technical performance study with acceptance criteria.

§ 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).