The following data is part of a premarket notification filed by Vamed Medical Instrument Co., Ltd. with the FDA for External Counterpulsation System, Soulaire.
| Device ID | K202108 |
| 510k Number | K202108 |
| Device Name: | External Counterpulsation System, Soulaire |
| Classification | Device, Counter-pulsating, External |
| Applicant | Vamed Medical Instrument Co., Ltd. 1 Of 8 Floor, 2# Building, No. 60, Langbao West Road, Chancheng District Foshan, CN 413200 |
| Contact | Ji Ma |
| Correspondent | Jet Li Guangzhou Keda Biological 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2020-08-28 |