FDA.reportPublic FDA data

Wellue/Viatom

Primary DI
06934440102212
Brand
Wellue/Viatom
Company
Shenzhen Viatom Technology Co.,Ltd.
Model
BP2 Blood Pressure Monitor
Published
2024-12-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193348000Blood Pressure MonitorShenzhen Viatom Technology Co., Ltd.2020-06-25DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934440102212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934440102212069344401022126934440102212

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421357243
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06934440102021VIATOM Pulse OximeterPO22025-11-12
06934440102977LEPU MEDICALPO22025-03-17
06934440103066Pulse OximeterPO22025-03-17
06934440103073Pulse OximeterPO2A2025-03-17
06934440103080Pulse OximeterPO2B2025-03-17
06934440102311ViatomPO6 Oxyfit Pulse Oximeter2023-12-12
06934440102069CheckmeBP2 Blood Pressure Monitor2024-12-24
06934440102588LEPU MEDICALBP2 Blood Pressure Monitor2024-12-24
06934440102618BP2 Blood Pressure MonitorBP2 Blood Pressure Monitor2024-12-24
06934440102748CheckmeBP2A Blood Pressure Monitor2024-12-24
06934440102755BP2A Blood Pressure MonitorBP2A Blood Pressure Monitor2024-12-24
06934440102762LEPU MEDICALBP2A Blood Pressure Monitor2024-12-24
06934440102809Pulse OximeterS92024-12-23
06934440102816Pulse OximeterS102024-12-23
06934440102823Pulse OximeterS112024-12-23
06934440102830Pulse OximeterS122024-12-23
06934440102847Pulse OximeterS132024-12-23
06934440102854Pulse OximeterS13B2024-12-23
06934440102861Pulse OximeterS142024-12-23
06934440102878Pulse OximeterS32024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850048674028HeartBeam ECG SystemHeartBeam, Inc.DPS2026-07-16
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00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911355N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
06927709404608JALIPShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
06927709404622WellWinkShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
06973912940419IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06973912940426IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03