The following data is part of a premarket notification filed by Vamed Medical Instrument Co., Ltd with the FDA for External Counterpulsation System.
| Device ID | K190683 |
| 510k Number | K190683 |
| Device Name: | External Counterpulsation System |
| Classification | Device, Counter-pulsating, External |
| Applicant | Vamed Medical Instrument Co., Ltd 1 Of 8 Floor, 2# Building, No. 60, Lang Bao West Road, Chancheng District Foshan, CN 528000 |
| Contact | Ji Mia |
| Correspondent | Jet Li Guangzhou KEDA Testing Tech Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN 510060 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-09-10 |
| Summary: | summary |