FDA.reportPublic FDA data

Etekcity Smart Blood Pressure Monitor

Primary DI
00817915020159
Brand
Etekcity Smart Blood Pressure Monitor
Company
Vesync (US) Corporation
Model
TMB-1583-BS
Published
2020-07-20
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
K120058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120058000TRANSTEK BLOOD PRESSURE MONITORZhongshan Transtek Electronics Co., Ltd.2012-01-31DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817915020156PackageGS118In Commercial Distribution
00817915020159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502015610817915020156
00817915020159008179150201598179150201590817915020159

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079578783
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817915020296Etekcity Smart Fitness ScaleEFS-A791-WUS2026-08-14
00817915020272Etekcity Smart Fitness ScaleEFS-A791-KUS2026-05-11
00817915020043ETEKCITY TENS Unit Electrode Pads(50x50mm)ETU-P122019-09-20
00817915020050ETEKCITY TENS Unit Electrode Pads(50x100mm)ETU-P122019-09-20
00817915020067Etekcity Smart Fitness ScaleESF932019-10-10
00817915020074Etekcity Smart Fitness ScaleFIT 8S2019-12-20
00817915020098Etekcity Smart Fitness ScaleESF172020-06-01
00817915020104Etekcity Smart Fitness ScaleESF182020-06-01
00817915020111Etekcity Smart Fitness ScaleESF242020-06-01
00817915020128Etekcity Smart Fitness ScaleESF282020-06-01
00817915020135Etekcity Smart Fitness ScaleESF372020-06-01
00817915020166Etekcity Smart Fitness ScaleESF14, ESF382020-08-01
00817915020180Etekcity Smart Fitness ScaleESF-5512021-05-31
00817915020197EtekcityEFS-E661-WUS2024-08-24
00817915020203EtekcityEFS-E661-KUS2024-08-24
00817915020210EtekcityEFS-A591S-KUST2024-11-04
00817915020234EtekcityEFS-C671-WUST2025-01-14
00817915020258Etekcity Neck Massager Heated ProENM-C221-WUS2025-03-31
00817915020265Etekcity Smart Fitness ScaleEFS-C651-WUS2025-07-01
00817915023211Etekcity Smart Fitness ScaleESF932024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947016YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012301AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012318AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012325AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012332AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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06973826012363AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012370AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012387AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09