FDA.reportPublic FDA data

ETEKCITY BLOOD PRESSURE MONITOR

Primary DI
00817915020029
Brand
ETEKCITY BLOOD PRESSURE MONITOR
Company
Vesync (US) Corporation
Model
EBP-UA5
Published
2019-05-14
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
K180435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180435000Arm Blood Pressure MonitorAlicn Medical (Shenzhen), Inc.2019-01-03DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817915020026PackageGS120In Commercial Distribution
00817915020029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502002610817915020026
00817915020029008179150200298179150200290817915020029

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
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
00817915028216Etekcity Smart Fitness ScaleEFS-A591S-WUST2021-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
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