Chrysalis Intelligence · Sponsors · Empatica S.r.l.

Empatica S.r.l.

Milan, IT · 7 510(k) clearances

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Total clearances
7
2022-11-20 → 2026-08-14
Last 12 months
2
Product codes
5
Most recent
2026-08-14
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
POS Physiological Signal Based Seizure Monitoring System Class II Neurology 2 2025-06-19
MWI — — — 2 2025-06-06
GYD Transducer, Tremor Class II Neurology 1 2026-08-14
LEL — — — 1 2025-12-22
DQA — — — 1 2022-11-20
Filings

All 510(k) clearances (7)

Date K-number Device Code Class Specialty
2026-08-14 K260374 Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal GYD Class II Neurology
2025-12-22 K252981 EmbraceMini LEL — —
2025-06-19 K250515 EpiMonitor POS Class II Neurology
2025-06-06 K242737 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal MWI — —
2024-02-15 K232915 EpiMonitor POS Class II Neurology
2023-10-30 K230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal MWI — —
2022-11-20 K221282 Empatica Health Monitoring Platform DQA — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence