FDA.reportPublic FDA data

External counterpulsation system, stationary

Definition
A noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.
GUDID devices
54
Last updated
2026-10-04 01:47:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06975435800096OmayOmay(Guangzhou) Med Technologies Co.,LtdOM-A-II2026-09-24
06971379470067PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.PECP/TI2025-04-15
06975435800058OmayOmay(Guangzhou) Med Technologies Co.,LtdOmay-A 2023-12-21
06971379470029ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.P-ECP/TI2017-12-04
00868331000409RejuvaHeartNORTH AMERICAN ECP INC.NCP-22017-10-17
00817980020740Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.Model AngioNew V2016-11-29
00817980020757Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.Model AngioNew V2016-11-29
00817980020788Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020795Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020801Vasomedical™ TS-4 EECP® Therapy SystemVASOMEDICAL, INC.Model TS-42016-11-29
00817980020818Vasomedical™ TS-4EECP® Therapy SystemVASOMEDICAL, INC.Model TS-42016-11-29
00817980020825Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020832Roll ECG Paper, 240 ft. (Model MC2)VASOMEDICAL, INC.Model MC22016-11-29
00817980020924Cuff Set, X-SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020931Cuff Set, SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020948Cuff Set, MediumVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020955Cuff Set, LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020962Cuff Set, X-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020979Cuff Set, XX-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020986Thigh Cuff, X-SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980020993Thigh Cuff, SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021006Thigh Cuff, MediumVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021013Thigh Cuff, LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021020Thigh Cuff, X-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021037Thigh Cuff, XX-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021044Calf Cuff, X-SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021051Calf Cuff, Small, Medium & LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021068Calf Cuff, X-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021075Calf Cuff, XX-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021082Bladder Set, X-SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021099Bladder Set, MediumVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021105Bladder Set, X-Large (should be used with XL and XXL cuffs)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021112Bladder Set, SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021129Bladder Set, LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021136Treatment Pants, X-SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021143Treatment Pants, SmallVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021150Treatment Pants, MediumVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021167Treatment Pants, LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021174Treatment Pants, X-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021181Treatment Pants, XX-LargeVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021211AnKle StrapVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021228TwiLoK™ Cuff Side Hose ConnectorVASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021235TwiLoK™ System Adapter for Hose (inserted into system table)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021242Hose, Set of 6 (Lumenair™)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021259Hose, Set of 6 (Models MC2, TS3, TS4)VASOMEDICAL, INC.Model TS-42016-11-29
00817980021266Hose, Single, (Models MC2, TS3, TS4 and Lumenair for Lower Thigh And Calf)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021273Hose, Single, Upper Thigh (Lumenair™)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021280Hose, Complete Set, Calf, Upper Thigh & Lower Thigh (AngioNew® V)VASOMEDICAL, INC.Model AngioNew V2016-11-29
00817980021297Hose Single, (250mm) (AngioNew® VI)VASOMEDICAL, INC.Model AngioNew VI2016-11-29
00817980021303Hose Single, (300mm) (AngioNew® VI)VASOMEDICAL, INC.Model AngioNew VI2016-11-29
00817980021310Hose, Set of 6 (AngioNew® VI)VASOMEDICAL, INC.Model AngioNew VI2016-11-29
00817980021358Patient Stop Cable (Model TS3)VASOMEDICAL, INC.Model TS32016-11-29
00817980021365Patient Stop Cable (Model TS4 and Lumenair™)VASOMEDICAL, INC.Model Lumenair2016-11-29
00817980021372Patient Stop Cable (AngioNew® V and VI)VASOMEDICAL, INC.Model AngioNew VI2016-11-29