Clearance Summary
Enhanced External Counter Pulsation Device Plus Omay-A received FDA 510(k) clearance under submission number K191955, sponsored by Omay(Guangzhou)Med Technologies Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-08-05.
- Submission: K191955
- Applicant / Sponsor: Omay(Guangzhou)Med Technologies Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5225
- Decision date: 2020-08-05
Classification & Regulation
This clearance is catalogued under FDA product code DRN and 21 CFR 870.5225, within the Cardiovascular review panel as a Class II device.