RenewTM NCP-5 External Counterpulsation System

Catalogue number NCP-5, listed by S2 Equipment LLC, United States, under Device, Counter-Pulsating, External. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26
3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Chongqing (1).

Chinese manufacturers registered for FDA product code DRN
Manufacturer City Province Registered as Device types
Vamed Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 1
Chongqing PSK-Health SCI-Tech Development Co., Ltd. Chongqing Chongqing Manufacturer 1
Omay(Guangzhou) MED Technologies Co., Ltd. Guangzhou Guangdong Repacker / relabeller 1

Record

Regulatory record for RenewTM NCP-5 External Counterpulsation System
Listed by S2 Equipment LLC, United States
FDA product code DRN
Device type Device, Counter-Pulsating, External
Device class Class 2
Regulation 21 CFR 870.5225
Establishment Contract manufacturer, Manufacturer
Record published 2018-06-25

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Latex Labelled latex-free
Label carries manufacturing date, serial number
Storage Handling environment temperature -15 to 50 °C; Handling environment humidity 10 to 95 % RH; Handling environment atmospheric pressure 45 to 105 KiloPascal

Catalogue Numbers

Catalogue numbers for RenewTM NCP-5 External Counterpulsation System
Catalogue number Size Status
NCP-5 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vasomedical™Lumenair™ Eecp® Therapy System Vasomedical, Inc. 2
Vasomedical™ AngioNew -V Eecp® Therapy System Vasomedical, Inc. 2
Vasomedical™ AngioNew -VI Eecp® Therapy System Vasomedical, Inc. 2
PSK, Air-bag Type Sequential External Counter-pulsation Device Chongqing PSK-Health SCI-Tech Development Co., Ltd. 2
ECP PSK Chongqing PSK-Health SCI-Tech Development Co., Ltd. 2
Hose, Single, Upper Thigh (Lumenair™) Vasomedical, Inc. 1
Calf Cuff, XX-Large Vasomedical, Inc. 1
Z-Fold ECG Paper, 147 ft. (Models TS3, and TS4 and Lumenair™) Vasomedical, Inc. 1
RejuvaHeart North American ECP Inc. 1
Calf Cuff, X-Small Vasomedical, Inc. 1
Bladder Set, Medium Vasomedical, Inc. 1
Nu Prep Gel, 4 oz (3 PK) Vasomedical, Inc. 1

Showing 12 of 67. All products under Device, Counter-Pulsating, External

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer