Cuff Set, Large Model Lumenair

• FDA 510(k) K033617 decided 1 Mar 2004 Active
• FDA GUDID UDI-DI 00817980020955 listed 29 Nov 2016 Listed

1. 1 Mar 2004 Cleared FDA 510(k) K033617
2. 29 Nov 2016 Listed FDA GUDID 00817980020955

Trade name

Cuff Set, Large

Generic name

External counterpulsation system, stationary

Model / Ref / Catalog

Model Lumenair, V23-0002

Primary DI / UDI-DI

00817980020955

510(k) Number

K033617 ↗

FDA product code

DRN

GMDN term

External counterpulsation system, stationary

Device class

Class II

Regulation number

870.5225

GUDID distribution status

In Commercial Distribution

Category: External counterpulsation system, stationary

Other devices filed under FDA product code DRN (Device, counter-pulsating, external).

• External Counterpulsation System, Soulaire by Vamed Medical Instrument Co., Ltd.
• CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM by Cardiomedics, Inc.
• CIRCULATOR BOOT by Circulator Boot Corp.
• GENESIS ECP by ScottCare Corporation
• ACS MODEL NCP-2 by Applied Cardiac Systems, Inc.
• CARDIASSIST EXTERNAL COUNTERPULSATION by Cardiassist Corp.
• AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE by External Counterpulsation Lab
• CPCA2000 COUNTERPULSATION SYSTEM by Cpca2000, Inc.
• Nicore Model NCP-1 External Counterpulsation Device by Nicore Equipment & Leasing, Inc.
• Pure Flow External Counter-Pulsation Device by Xtreem Pulse, LLC

• 2GB SD Memory Card Model 1303

  Class II

  FDA 510(k) K111180 Active Cleared 28 Jun 2011 GUDID on market

• Treatment Pants, Small Model Lumenair

  Class II

  FDA 510(k) K033617 Active Cleared 1 Mar 2004 GUDID on market

• Thigh Cuff, Medium Model Lumenair

  Class II

  FDA 510(k) K033617 Active Cleared 1 Mar 2004 GUDID on market

• Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) Model Lumenair

  Class II

  FDA 510(k) K033617 Active Cleared 1 Mar 2004 GUDID on market

See all devices from Vasomedical, Inc. →