Enhanced External Counter Pulsation Device Plus Omay-A
FDA 510(k) K191955 · Omay(Guangzhou)Med Technologies Co., Ltd.
510(k) numberK191955
Submission
- Device name
- Enhanced External Counter Pulsation Device Plus Omay-A
- Applicant
- Omay(Guangzhou)Med Technologies Co., Ltd.
Guangzhou, CN - Received
- July 22, 2019
- Decision date
- August 5, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRN – Device, Counter-Pulsating, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5225
- Specialty
- Cardiovascular
Other 510(k)s with product code DRN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250756 | Pression Wave PRO External Counter-Pulsation SystemDRN · Traditional | Pression, Inc. | 12/22/2025SE |
| K202108 | External Counterpulsation System, SoulaireDRN · Special | Vamed Medical Instrument Co., Ltd. | 08/28/2020SE |
| K190683 | External Counterpulsation SystemDRN · Traditional | Vamed Medical Instrument Co., Ltd. | 09/10/2019SE |
| K173483 | Pure Flow External Counter-Pulsation DeviceDRN · Traditional | Xtreem Pulse, LLC | 05/30/2018SE |
| K152115 | Renew NCP-5 External Counterpulsation SystemDRN · Traditional | Stage 2 Innovations | 12/17/2015SE |
| K130439 | External Counterpulsation Device with SP02 MornitoringDRN · Traditional | Chongqing Psk Sci-Tech Development Co., Ltd. | 12/12/2013SE |
| K082134 | Circulator BootDRN · Traditional | Circulator Boot Corp. | 05/07/2009SE |
| K081359 | Genesis EcpDRN · Special | Scottcare Corporation | 05/29/2008SE |
| K052611 | Ecp Health System, Model 2005DRN · Traditional | Ecp Health, Inc. | 04/26/2006SE |
| K050172 | Cardiassist Counter Pulsation System Series 4000/5000DRN · Traditional | Cardiomedics, Inc. | 03/31/2005SE |
Questions and answers
When was Enhanced External Counter Pulsation Device Plus Omay-A cleared by the FDA?
Enhanced External Counter Pulsation Device Plus Omay-A (K191955) received a 510(k) decision of Substantially Equivalent on August 5, 2020, 380 days after the submission was received.
What is the product code of K191955?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.