FDA.reportPublic FDA data

Empatica

Primary DI
00853858006584
Brand
Empatica
Company
EMPATICA SRL
Model
EmbracePlus2 Stretchable Band - Black
Catalog number
EBP2-1G-FB-B
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLContinuous Measurement Thermometer
GZODevice, Galvanic Skin Response Measurement
LELDevice, Sleep Assessment
MSXSystem, Network And Communication, Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
GZODevice, Galvanic Skin Response MeasurementNeurology2
LELDevice, Sleep AssessmentNeurology2
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230457000Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.2023-10-30MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853858006584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853858006584008538580065848538580065840853858006584

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, clinicalAn assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
430141750
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853858006522EmbraceMiniEmbraceMini FKM bandEMBM-1G-FB-B2026-02-16
00853858006546Empatica Health Monitoring PlatformEmbracePlus2 Silicone Band - White EBP2-1G-SB-W2026-02-16
00853858006713EmbraceMiniEmbraceMini stretchable bandEMBM-1G-SB-B2026-02-16
00853858006751Empatica Health Monitoring PlatformEmbracePlus2 with Elastic StrapEBP2-1G-FB-B2026-02-16
00853858006324Empatica E4E4E42021-09-30
00853858006379EpiMonitorEpiMonitor App iOS2024-08-14
00853858006386EpiMonitorEpiMonitor App Android2024-08-14
00853858006232Empatica Health Monitoring PlatformEmbracePlusEMBP-CC-MS2022-11-24
00853858006249Empatica Health Monitoring PlatformCare App iOS2022-11-24
00853858006256Empatica Health Monitoring PlatformCare App Android Version2022-11-24
00853858006263Empatica Health Monitoring PlatformCare Portal2022-11-24
00853858006102Embrace2EmbraceEM2-MB-S2020-02-11
00853858006119Embrace2EmbraceEM2-BB-S2020-02-11
00853858006126Embrace2EmbraceEM2-SG-S2020-02-11
00853858006133Embrace2EmbraceEM2-FP-S2020-02-11
00853858006140Embrace2EmbraceEM2-SB-S2020-02-11
08538580061026Embrace2EmbraceEM2-MB-S2018-11-09
08538580061194Embrace2EmbraceEM2-BB-S2018-11-09
08538580061262Embrace2EmbraceEM2-SG-S2018-11-09
08538580061330Embrace2EmbraceEM2-FP-S2018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
00860011800613CardioTagCARDIOSENSE, INC.DRG2026-10-14
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.MSX2026-08-26