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EpiWatch
Epiwatch, Inc. · Model 1 · UDI-DI 00860013047702
POS
Prescription
1
510(k) clearances
4
Adverse events
1
Recalls
6
Facilities
Description
Seizure detection algorithm app for tonic clonic seizure detection, alerting and monitoring
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-13 | EMPATICA SRL | May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.