EMPATICA SRL
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0159-2024 | Class II | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up | July 13, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252981 | EmbraceMini | December 22, 2025 |
| K250515 | EpiMonitor | June 19, 2025 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | June 6, 2025 |
| K232915 | EpiMonitor | February 15, 2024 |
| K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | October 30, 2023 |
| K221282 | Empatica Health Monitoring Platform | November 20, 2022 |
| K181861 | Embrace | December 20, 2018 |
| K172935 | Embrace | January 26, 2018 |