FDA.reportPublic FDA data

Etekcity Blood Pressure Monitor

Primary DI
10817915029159
Brand
Etekcity Blood Pressure Monitor
Company
ETEKCITY CORPORATION
Model
EBP-M071S-WUS
Published
2022-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10817915029159PackageGS120In Commercial Distribution
00817915029152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502915910817915029159
00817915029152008179150291528179150291520817915029152

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817915020262Etekcity Smart Fitness ScaleEFS-C651-WUS2025-07-01
10817915020255Etekcity Neck Massager Heated ProENM-C221-WUS2025-03-31
10817915020231EtekcityEFS-C671-WUST2025-01-14
10817915020217EtekcityEFS-A591S-KUST2024-11-04
10817915020194EtekcityEFS-E661-WUS2024-08-24
10817915020200EtekcityEFS-E661-KUS2024-08-24
10817915023218Etekcity Smart Fitness ScaleESF932024-03-22
10817915028213Etekcity Smart Fitness ScaleEFS-A591S-WUST2021-08-24
10817915028220Etekcity Smart Fitness ScaleEFS-A591S-KUST2021-08-24
10817915028237Etekcity Smart Fitness ScaleEFS-A591S-WUSR2021-08-24
10817915028244Etekcity Smart Fitness ScaleEFS-A591S-KUSR2021-08-24
10817915020187Etekcity Smart Fitness ScaleESF-5512021-05-31
10817915020163Etekcity Smart Fitness ScaleESF14, ESF382020-08-01
10817915020071Etekcity Smart Fitness ScaleFIT 8S2019-12-20
10817915020064Etekcity Smart Fitness ScaleESF932019-10-10
20817915020047ETEKCITY TENS Unit Electrode Pads(50x50mm)ETU-P122019-09-20
20817915020054ETEKCITY TENS Unit Electrode Pads(50x100mm)ETU-P122019-09-20

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Primary DI, Brand, Company table
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