FDA.reportPublic FDA data

Beat

Primary DI
00863398000287
Brand
Beat
Company
LEXINGTON WELLNESS HOLDINGS INC.
Model
B02T
Device description
Upper arm blood pressure monitor.
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172171000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10863398000284PackageGS120In Commercial Distribution
00863398000287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086339800028410863398000284
00863398000287008633980002878633980002870863398000287

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Regulatory Flags#

DUNS number
079437338
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860005561759TouchJPD-500D2025-10-30
00860005561742BeatJPD-HA1002025-02-24
10860005561749BeatJPD-HA1002025-02-24
00860005561735BalanceS-5 (200kg)2023-08-16
10860005561732BalanceS-5 (200kg)2023-08-16
00863398000225BeatF1701T2023-06-26
00860005561728TouchJPD-500G2021-08-31
10860005561725TouchJPD-500G2021-08-31
00863398000270BalanceS-52020-10-30
00860005561704ScanG-427BS2021-02-01
00863398000294ScanG-427B2021-02-01
00834450009142IdealSmartS-32019-01-15
00863398000249BalanceS-32019-01-15
00863398000263BalanceS-42019-01-15
10863398000277BalanceS-52020-10-30
10863398000284BeatB02T2020-10-01
00834450009159IdealSmartS-32019-01-15
10863398000246BalanceS-32019-01-15
10863398000260BalanceS-42019-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911225AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911232AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911249KPMNShenzhen Urion Technology Co., LtdDXN2026-06-03
06976528061608Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06976528061615Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-03
06932825303216TeleRPMGuangdong Transtek Medical Electronics Co.,LtdDXN2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2026-06-02
06920485308467BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DXN2026-06-01
06976528060335Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060342Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060359Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060366Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060373Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06976528060380Arm Blood Pressure MonitorShenzhen HanHan Technology Co., LtdDXN2026-06-01
06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
06932825306088PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
06932825306132PulseGuangdong Transtek Medical Electronics Co.,LtdDXN2026-05-29
00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
00845717015509SmartHeartVERIDIAN HEALTHCARE LLCDXN2026-05-27
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27