External Counterpulsation System, Soulaire
FDA 510(k) K202108 · Vamed Medical Instrument Co., Ltd.
510(k) numberK202108
Submission
- Device name
- External Counterpulsation System, Soulaire
- Applicant
- Vamed Medical Instrument Co., Ltd.
Foshan, CN - Received
- July 30, 2020
- Decision date
- August 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| K250756 | Pression Wave PRO External Counter-Pulsation SystemDRN · Traditional | Pression, Inc. | 12/22/2025SE |
| K191955 | Enhanced External Counter Pulsation Device Plus Omay-ADRN · Traditional | Omay(Guangzhou)Med Technologies Co., Ltd. | 08/05/2020SE |
| 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 |
More from Cardiomedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K190683 | External Counterpulsation SystemDRN · Traditional | 09/10/2019SE |
Questions and answers
When was External Counterpulsation System, Soulaire cleared by the FDA?
External Counterpulsation System, Soulaire (K202108) received a 510(k) decision of Substantially Equivalent on August 28, 2020, 29 days after the submission was received.
What is the product code of K202108?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.