EECP Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation EECP MC-2 External Counter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020857 FDA 510(k)
- FDA Product Code
- DRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5225 FDA 510(k)
- Regulation Number
- 870.5225 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EECP Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation EECP MC-2 External Counter is a non-invasive external counterpulsation device. It is classified as a Device, Counter-Pulsating, External under regulation 870.5225 and is intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
The device is supplied by Vasomedical, Inc. and received FDA 510(k) clearance under K020857 on June 14, 2002, with a determination of substantially equivalent. It is a Class II medical device with product code DRN and is manufactured at 180 Linden Ave., Westbury, NY 11590.
Frequently asked questions
What is the EECP Therapy System Model TS3 used for?
The EECP Therapy System Model TS3 is a non-invasive external counterpulsation device intended for treating patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.
How is the EECP Therapy System supplied?
The device is supplied by Vasomedical, Inc. and is manufactured at 180 Linden Ave., Westbury, NY 11590. It includes pulse oximetry and enhanced external counterpulsation capabilities.
What is the regulatory status of the EECP Therapy System Model TS3?
The device received FDA 510(k) clearance under K020857 on June 14, 2002, with a determination of substantially equivalent. It is classified as a Class II medical device with product code DRN.
Is the EECP Therapy System reusable or single-use?
The device information does not specify whether the EECP Therapy System Model TS3 is designed for single-use or multiple uses. For specific usage instructions, please consult the manufacturer's documentation or contact Vasomedical, Inc.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Eecp Therapy System Model Ts3 With Pulse Oximetry and Enhanced External ..., EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY… - FDA.report, Vasomeditech
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020857 | Class II | Active |
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Manufacturer
- Manufacturer
- Vasomedical, Inc.
Sources (1)
- FDA 510(k) K020857 24 fields · synced Sep 21, 2026