510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K260374Substantially Equivalent

Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal

EMPATICA S.r.l., Milan, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260374 is the FDA 510(k) clearance record for Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus; EmbraceMini; Empatica Care; PKG Monitor by Empatica; Care Portal, a class II device, cleared for Empatica S.r.l. on under FDA product code GYD (Transducer, Tremor). FDA records list 9 510(k) clearances for Empatica S.r.l., from to . As of , FDA records show no recalls naming K260374.

Clearance record

Decision date
Received
(190 days to decision)
Product code
GYD Transducer, Tremor
Regulation
21 CFR 882.1950
Device class
Class II
Review panel
Neurology
Applicant
Empatica S.r.l. Via Enrico Stendhal, 36, Milan, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GYD

Trailing 12 months
3 clearances under product code GYD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code GYD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20262
September 20260
October 20260