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ECP Health System, Model 2005

by Ecp Health, Inc.

510(k) K052611

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052611 Date26 Apr 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRN
Device Class
Class II
Regulation
21 CFR Part 870.5225
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ECP Health System, Model 2005 is a non-invasive, microprocessor-controlled external counterpulsation device. It utilizes air cuffs applied to calves, lower thighs, and upper thighs to enhance coronary artery perfusion and reduce cardiac workload. This device is classified as a Device, Counter-pulsating, External with product code DRN.

The ECP Health System, Model 2005 is intended for the treatment of patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock, and congestive heart failure. It is a Class II device under special controls with FDA 510(k) clearance K052611, issued on April 26, 2006. The device is manufactured by Ecp Health, Inc. in Fort Worth, US.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ECP Health System Model 2005 used for?

    The ECP Health System Model 2005 is a non-invasive device that enhances coronary artery perfusion and reduces cardiac workload. It is intended for treating patients with stable or unstable angina pectoris, acute myocardial infarction, cardiogenic shock, and congestive heart failure.

  • How is the ECP Health System Model 2005 supplied and is it single-use or reusable?

    The device utilizes air cuffs applied to calves, lower thighs, and upper thighs. The device itself is reusable, but the cuffs may have specific usage guidelines that should be followed according to the manufacturer's instructions to ensure proper hygiene and functionality.

  • What are the regulatory specifications for the ECP Health System Model 2005?

    The ECP Health System Model 2005 is classified as a Class II device under special controls with FDA 510(k) clearance K052611, issued on April 26, 2006. It is manufactured by Ecp Health, Inc. in Fort Worth, US, and is intended for specific cardiovascular conditions as cleared by the FDA.

  • Are there different sizes or models of the ECP Health System available?

    The device is specifically identified as Model 2005. While the air cuffs are designed to fit different body areas (calves, lower thighs, and upper thighs), the information provided does not specify multiple size options or additional models beyond the Model 2005.