FDA.reportPublic FDA data

ANNE Chest Sensor Kit

Primary DI
00850064210002
Brand
ANNE Chest Sensor Kit
Company
Sibel Health Inc.
Model
900-00007
Device description
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
FLLThermometer, Electronic, Clinical
KMIMonitor, Bed Patient
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
KMIMonitor, Bed PatientGeneral Hospital1
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240251000ANNE ChestSibel Health, Inc.2024-06-03DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064210002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064210002008500642100028500642100020850064210002

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple vital physiological parameter monitorA portable assembly of electrically-powered devices intended to be worn by an ambulatory patient in a healthcare setting for intermittent assessment or continuous monitoring of several vital physiologic parameters [e.g., electrocardiogram (ECG), respiration rate, haemoglobin oxygen saturation (SpO2)] while allowing freedom of movement (e.g., in step-down care areas). It includes processing hardware to be used with dedicated software (that may be pre-installed); the sensors, probes, and/or electrodes are not included. It typically incorporates a monitoring screen and may allow communication with a stationary device (e.g., off-the shelf computer).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
093772547
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf Box900-000722025-12-17
00850064210286ANNE Link Mobile900-000692025-12-11
00850064210200Sibel Spacelabs Trek Chest Patch900-000392025-04-02
00850064210217Sibel Spacelabs Trek Finger Patch900-000412025-04-02
00850064210224Sibel Spacelabs Trek Charger900-000462025-04-02
00850064210231Sibel Spacelabs Finger Patch Adhesive 3 day900-000422025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch Adhesive900-000622025-04-02
00850064210255Sibel Spacelabs Trek Blood Pressure Cuff900-000452025-04-02
00850064210262Sibel Spacelabs Trek Tablet900-000432025-04-02
00860004541745ANNE Chest810-000122025-04-02
00860004541752ANNE Limb810-000132025-04-02
00850064210125ANNE Limb Adhesive Shelf Box900-000112025-03-27
00850064210163Central Hub CMS900-000132025-03-27
00850064210194Central Hub Speaker900-000042025-03-27
008500642100197-Day ANNE Chest Adhesive Pouch900-000382025-03-26
008500642100261-Day ANNE Chest Adhesive Pouch900-000142025-03-26
00850064210057ANNE Bedside Wireless Charger900-000082025-03-26
00850064210088ANNE Limb Sensor Kit900-000032025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf Box900-000102025-03-26
00850064210132ANNE View Patient Monitor 900-000122025-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FLL2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
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
06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
06942284618073One Step®JOYTECH HEALTHCARE CO.,LTDFLL2026-05-29
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.DRG2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27