K191955 is an FDA 510(k) clearance for the Enhanced External Counter Pulsation Device Plus Omay-A. This device is classified as a Device, Counter-pulsating, External (Class II - Special Controls, product code DRN).
Submitted by Omay(Guangzhou)Med Technologies Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 5, 2020, 380 days after receiving the submission on July 22, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5225.
| 510(k) Number | K191955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2019 |
| Decision Date | August 05, 2020 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRN - Device, Counter-pulsating, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5225 |