Huawen
External counterpulsation Systems
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Chongqing (1).
| 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
| Listed by | Vamed Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | DRN |
| Device type | Device, Counter-Pulsating, External |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5225 |
| Establishment | Manufacturer |
| Record published | 2026-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Soulaire | In distribution |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202108 | 2020-08-28 |
| K190683 | 2019-09-10 |
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.