Enhanced External Counter Pulsation Device Plus Omay-A
FDA 510(k) clearance K191955 · decided 2020-08-05
Clearance details
- K-number
- K191955
- Device name
- Enhanced External Counter Pulsation Device Plus Omay-A
- Applicant
- Omay(Guangzhou)Med Technologies Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-22
- Decision date
- 2020-08-05
- Days to decision
- 380 days
- Clearance type
- Traditional
- Product code
- DRN
- Device class
- 2
- Regulation number
- 870.5225
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Guangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Pression Wave PRO External Counter-Pulsation System (K250756) | Pression, Inc. | 2025-12-22 |
| External Counterpulsation System, Soulaire (K202108) | Vamed Medical Instrument Co., Ltd. | 2020-08-28 |
| External Counterpulsation System (K190683) | Vamed Medical Instrument Co., Ltd. | 2019-09-10 |
| Pure Flow External Counter-Pulsation Device (K173483) | Xtreem Pulse, LLC | 2018-05-30 |
| Renew NCP-5 External Counterpulsation System (K152115) | Stage 2 Innovations | 2015-12-17 |
| EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING (K130439) | Chongqing Psk Sci-Tech Development Co., Ltd. | 2013-12-12 |
| CIRCULATOR BOOT (K082134) | Circulator Boot Corp. | 2009-05-07 |
| GENESIS ECP (K081359) | Scottcare Corporation | 2008-05-29 |
| ECP HEALTH SYSTEM, MODEL 2005 (K052611) | Ecp Health, Inc. | 2006-04-26 |
| CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 (K050172) | Cardiomedics, Inc. | 2005-03-31 |
| ACS MODEL NCP-2 (K042413) | Applied Cardiac Systems | 2004-12-09 |
| EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (K033617) | Vasomedical, Inc. | 2004-03-01 |
Recalls involving this device
No recalls on record reference this clearance.