Bladder Set, Large Model Lumenair

• FDA 510(k) K033617 decided 1 Mar 2004 Active
• FDA GUDID UDI-DI 00817980021129 listed 29 Nov 2016 Listed

1. 1 Mar 2004 Cleared FDA 510(k) K033617
2. 29 Nov 2016 Listed FDA GUDID 00817980021129

Trade name

Bladder Set, Large

Generic name

External counterpulsation system, stationary

Model / Ref / Catalog

Model Lumenair, V23-0010

Primary DI / UDI-DI

00817980021129

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).

• ECP Health System, Model 2005 by Ecp Health, Inc.
• EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP by S-Tct Health, Inc.
• ANGIONEW-IV by Living Data Technologies Corporation
• Enhanced External Counter Pulsation Device Plus Omay-A by Omay(Guangzhou)Med Technologies Co., Ltd.
• Pression Wave PRO External Counter-Pulsation System by Pression, Inc.
• NICORE MODEL ESP -1 by Nicore Equipment & Leasing, Inc.
• CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 by Cardiomedics, Inc.
• EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING by Chongqing Psk Sci-Tech Development Co., Ltd.
• THE CIRCULATOR BOOT by Circulator Boot Corp.
• CARDIOMEDICS ECP SYSTEM by Cardiomedics, Inc.

• 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. →