FDA.reportPublic FDA data

PSK, Air-bag Type Sequential External Counter-pulsation Device

Primary DI
06971379470067
Brand
PSK, Air-bag Type Sequential External Counter-pulsation Device
Company
Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
Model
PECP/TI
Published
2025-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DRNDevice, Counter-Pulsating, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRNDevice, Counter-Pulsating, ExternalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130439000EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORINGChongqing Psk Sci-Tech Development Co., Ltd.2013-12-12DRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971379470067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971379470067069713794700676971379470067

GMDN Terms#

Term, Definition table
TermDefinition
External counterpulsation system, stationaryA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527142177
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971379470074PSK, Air-bag Type Sequential External Counter-pulsation DevicePECP/TM2025-04-15
06971379470012ECP PSKP-ECP/TM2017-12-04
06971379470029ECP PSKP-ECP/TI2017-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979448890020HuawenVamed Medical Instrument Co.,LtdDRN2026-04-17
06971379470074PSK, Air-bag Type Sequential External Counter-pulsation DeviceChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2025-04-15
06975435800058OmayOmay(Guangzhou) Med Technologies Co.,LtdDRN2023-12-21
00865089000316RenewTM NCP-5 External Counterpulsation System S2 Equipment LLCDRN2018-06-25
06971379470012ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
06971379470029ECP PSKChongqing PSK-Health Sci-Tech Development Co.,Ltd.DRN2017-12-04
00868331000409RejuvaHeartNORTH AMERICAN ECP INC.DRN2017-10-17
08883000001640RenewTM NCP-5 External Counterpulsation System RENEW GROUP PRIVATE LIMITEDDRN2017-03-15
00817980020740Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020757Vasomedical™ AngioNew -V EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020764Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020771Vasomedical™ AngioNew -VI EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020788Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020795Vasomedical™Lumenair™ EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020801Vasomedical™ TS-4 EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020818Vasomedical™ TS-4EECP® Therapy SystemVASOMEDICAL, INC.DRN2016-11-29
00817980020825Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
00817980020832Roll ECG Paper, 240 ft. (Model MC2)VASOMEDICAL, INC.DRN2016-11-29
00817980020849Nu Prep Gel, 4 oz (3 PK)VASOMEDICAL, INC.DRN2016-11-29
00817980020856Signa Electrode Gel, 8 ozVASOMEDICAL, INC.DRN2016-11-29
00817980020863Signa Electrode Gel, 2 ozVASOMEDICAL, INC.DRN2016-11-29
008179800208703 Lead Integrated ECG Cable (AngioNew® V & VI)VASOMEDICAL, INC.DRN2016-11-29
008179800208873 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™)VASOMEDICAL, INC.DRN2016-11-29
008179800208943 Lead Integrated ECG Cable with adapter (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020900ECG Cable Adaptor-for use with V10-0017 (Model TS3)VASOMEDICAL, INC.DRN2016-11-29
00817980020917Electrodes (600 per case)VASOMEDICAL, INC.DRN2016-11-29
00817980020924Cuff Set, X-SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020931Cuff Set, SmallVASOMEDICAL, INC.DRN2016-11-29
00817980020948Cuff Set, MediumVASOMEDICAL, INC.DRN2016-11-29
00817980020955Cuff Set, LargeVASOMEDICAL, INC.DRN2016-11-29