FDA.reportPublic FDA data

Empatica Health Monitoring Platform

Primary DI
00853858006263
Brand
Empatica Health Monitoring Platform
Company
EMPATICA SRL
Model
Care Portal
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLThermometer, Electronic, Clinical
GZODevice, Galvanic Skin Response Measurement
LELDevice, Sleep Assessment

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221282000Empatica Health Monitoring PlatformEmpatica S.r.l.2022-11-20DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853858006263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853858006263008538580062638538580062630853858006263

GMDN Terms#

Term, Definition table
TermDefinition
Multiple vital physiological parameter monitoring system, home-useAn assembly of electrically-powered devices designed to be used by a layperson in the home 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
00853858006584EmpaticaEmbracePlus2 Stretchable Band - BlackEBP2-1G-FB-B2025-06-26
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
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
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
00884392020613Safety 1stDOREL JUVENILE GROUP, INC.FLL2026-05-28
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27