FDA.reportPublic FDA data

EmbraceMini

Primary DI
00853858006522
Brand
EmbraceMini
Company
EMPATICA SRL
Model
EmbraceMini FKM band
Catalog number
EMBM-1G-FB-B
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring
LELDevice, Sleep Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2
LELDevice, Sleep AssessmentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853858006522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853858006522008538580065228538580065220853858006522

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
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
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
05065013876061Sword ThriveSWORD HEALTH, S.A.ISD2026-06-02
08717524641085Lode B.V.Lode B.V.ISD2026-06-01
08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006546Empatica Health Monitoring PlatformEMPATICA SRLLEL2026-02-16
00853858006713EmbraceMiniEMPATICA SRLLEL2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006751Empatica Health Monitoring PlatformEMPATICA SRLLEL2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00853858006584EmpaticaEMPATICA SRLLEL2025-06-26
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850068747092Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747122Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747139Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747146Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747153Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747177Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07