Consulting Wallah › Device Explorer › Other devices › External counterpulsation system, stationary
Device Explorer · FDA GUDID · GMDN 61282

External counterpulsation system, stationary

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 includ

US‑registered devices53in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Vasomedical, Inc.4992%
Omay(Guangzhou) Med Technologies Co.,Ltd24%
Chongqing Psk-Health Sci-Tech Development Co.,Ltd.12%
North American Ecp Inc.12%

Top labelers

CompanyDevicesShare
Vasomedical, Inc.4992%
Omay(Guangzhou) Med Technologies Co.,Ltd24%
Chongqing Psk-Health Sci-Tech Development Co.,Ltd.12%
North American Ecp Inc.12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OmayPSK, Air-bag Type Sequential External Counter-puRejuvaHeartPatient Stop Cable (AngioNew® V and VI)Patient Stop Cable (Model TS4 and Lumenair™)Patient Stop Cable (Model TS3)Hose, Set of 6 (AngioNew® VI)Hose Single, (300mm) (AngioNew® VI)Hose Single, (250mm) (AngioNew® VI)Hose, Complete Set, Calf, Upper Thigh & Lower ThHose, Single, Upper Thigh (Lumenair™)Hose, Single, (Models MC2, TS3, TS4 and LumenairHose, Set of 6 (Models MC2, TS3, TS4)Hose, Set of 6 (Lumenair™)TwiLoK™ System Adapter for Hose (inserted into sTwiLoK™ Cuff Side Hose Connector

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DRNDevice, counter-pulsating, external49
DRNDevice, Counter-Pulsating, External5

GMDN & GCC registration

  • GMDN code 61282 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 94% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 2Length (Inch) · 2Width (Inch) · 2

Use these as the dimensions to specify in a tender line.

How many external counterpulsation system, stationary products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External counterpulsation system, stationary", from 4 companies. The largest labeler is Vasomedical, Inc. with 92% of records.

Which FDA product codes apply?

DRN (Device, counter-pulsating, external), DRN (Device, Counter-Pulsating, External)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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