Omay-A
by Omay(Guangzhou)Med Technologies Co., Ltd.
Omay-A is a Class II device made by Omay(Guangzhou)Med Technologies Co., Ltd., listed in FDA GUDID since 21 Dec 2023 (UDI-DI 06975435800058), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06975435800058 | Date21 Dec 2023 | StatusListed |
Official records
- AccessGUDID record 06975435800058
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Omay
- Generic name
- External counterpulsation system, stationary
- Model / reference
- Omay-A
- Primary DI / UDI-DI
- 06975435800058
- FDA product code
- DRN
- GMDN term
- External counterpulsation system, stationary
- Device class
- Class II
- Regulation number
- 870.5225
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices
Other devices filed under FDA product code DRN (Device, Counter-Pulsating, External).
- ACS MODEL NCP-2 by Applied Cardiac Systems, Inc.
- CARDIASSIST EXTERNAL COUNTERPULSATION by Cardiassist Corp.
- AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE by External Counterpulsation Lab
- CPCA2000 COUNTERPULSATION SYSTEM by Cpca2000, Inc.
- Nicore Model NCP-1 External Counterpulsation Device by Nicore Equipment & Leasing, Inc.
- Pure Flow External Counter-Pulsation Device by Xtreem Pulse, LLC
- Circulator Miniboot by Circulator Boot Corp.
- EECP Therapy System Model TS3 with Pulse Oximetry and Enhanced External Counterpulsation EECP MC-2 External Counter by VASOMEDICAL, INC.
- The Circulator Boot by Circulator Boot Corp.
- Vasogenics EECP-MC2 by Vasogenics, Inc.