FDA.reportPublic FDA data

AILE Electronic Sphygmomanometers

Primary DI
06972480913047
Brand
AILE Electronic Sphygmomanometers
Company
Jiangxi Aicare Medical Technology Co., Ltd.
Model
X8
Device description
Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home.
Published
2023-03-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K221040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221040000Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11)Jiangxi Aicare Medical Technology Co., Ltd.2022-08-31DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972480913047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972480913047069724809130476972480913047

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
554530454
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972480913269COOCEER Electronic SphygmomanometersX82023-08-31
06972480913061AILE fingertip pulse oximeterW0112023-04-01
06972480912996AILE Electronic SphygmomanometersX12023-03-04
06972480913009AILE Electronic SphygmomanometersX22023-03-04
06972480913023AILE Electronic SphygmomanometersX62023-03-04
06972480913030AILE Electronic SphygmomanometersX72023-03-04
06972480913054AILE Electronic SphygmomanometersX112023-03-04
06972480916383AILE Electronic SphygmomanometersX52023-03-04

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Primary DI, Brand, Company table
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