The following data is part of a premarket notification filed by Omay(guangzhou)med Technologies Co., Ltd. with the FDA for Enhanced External Counter Pulsation Device Plus Omay-a.
| Device ID | K191955 |
| 510k Number | K191955 |
| Device Name: | Enhanced External Counter Pulsation Device Plus Omay-A |
| Classification | Device, Counter-pulsating, External |
| Applicant | Omay(Guangzhou)Med Technologies Co., Ltd. Room 302,3F, No. 600-1, Guangshan 2nd Road, Tianhe Guangzhou, CN |
| Contact | Peixian Su |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District Shenzhen, CN 518067 |
| Product Code | DRN |
| CFR Regulation Number | 870.5225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-22 |
| Decision Date | 2020-08-05 |