RejuvaHeart NCP-2
RejuvaHeart NCP-2 (No) is a Class II device made by North American Ecp Inc., listed in FDA GUDID since 17 Oct 2017 (UDI-DI 00868331000409), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00868331000409 | Date17 Oct 2017 | StatusListed |
Official records
- AccessGUDID record 00868331000409
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- RejuvaHeart
- Generic name
- External counterpulsation system, stationary
- Model / Ref / Catalog
- NCP-2, No
- Primary DI / UDI-DI
- 00868331000409
- FDA product code
- DRN
- GMDN term
- External counterpulsation system, stationary
- Device class
- Class II
- Regulation number
- 870.5225
- GUDID distribution status
- In Commercial Distribution
- Size
- Height — 29 InchLength — 80 InchWidth — 35.25 InchWidth — 30 InchHeight — 66.5 InchLength — 18.5 Inch
Similar devices
Other devices filed under FDA product code DRN (Device, Counter-Pulsating, External).
- EXTERNAL COUNTERPULSATION (ECP) MODEL US-ECP by S-Tct Health, Inc.
- EECP THERAPY SYSTEM, MODEL TS3 by VASOMEDICAL, INC.
- ANGIONEW-IV by Living Data Technologies Corporation
- Enhanced External Counter Pulsation Device Plus Omay-A by Omay(Guangzhou)Med Technologies Co., Ltd.
- EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY by VASOMEDICAL, INC.
- 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.