ECP PSK
2 catalogue numbers from P-ECP/TI, listed by Chongqing PSK-Health SCI-Tech Development Co., Ltd., China, under Device, Counter-Pulsating, External. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Chongqing PSK-Health SCI-Tech Development Co., Ltd., China |
|---|---|
| FDA product code | DRN |
| Device type | Device, Counter-Pulsating, External |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5225 |
| Establishment | Manufacturer |
| 510(k) | K130439 |
| Record published | 2017-12-04 |
| Record revised | 2020-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2020-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P-ECP/TI | Withdrawn | |
| P-ECP/TM | Withdrawn |
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 |
| 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 |
| Hose Single, (250mm) (AngioNew® VI) | Vasomedical, Inc. | 1 |
Showing 12 of 67. All products under Device, Counter-Pulsating, External
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130439 | 2013-12-12 |
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.