K202108 is an FDA 510(k) clearance for the External Counterpulsation System, Soulaire. This device is classified as a Device, Counter-pulsating, External (Class II - Special Controls, product code DRN).
Submitted by Vamed Medical Instrument Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on August 28, 2020, 29 days after receiving the submission on July 30, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5225.
| 510(k) Number | K202108 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2020 |
| Decision Date | August 28, 2020 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRN - Device, Counter-pulsating, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5225 |