FDA.reportPublic FDA data

YUWELL Electronic Blood Pressure Monitor

Primary DI
06933257947016
Brand
YUWELL Electronic Blood Pressure Monitor
Company
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Model
YE660D PRO
Device description
The measuring method for the device is oscillometric method. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate.
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K200939000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200939000Electronic Blood Pressure MonitorJiangsu Yuyue Medical Equipment & Supply Co., Ltd.2020-08-20DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16933257947013PackageGS110In Commercial Distribution
06933257947016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693325794701316933257947013
06933257947016069332579470166933257947016

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.

Regulatory Flags#

DUNS number
528704000
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
06933257920187Electronic Blood Pressure MonitorYE650AR2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorYE630CR2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorYE8800AR2026-10-09
06933257947023Electronic Blood Pressure MonitorYE660E PRO2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorYE680B PRO2026-10-09
06933257923157YUWELL® Infrared ThermometerYT-32026-08-19
06933257952744YUWELL® Infrared ThermometerYHW-62026-08-19
06933257952751YUWELL® Infrared ThermometerYHW-52026-08-19
06933257929432YUWELL® Infrared Ear ThermometerYHT108YHT1080012026-05-07
06933257930711YUWELL® Infrared Ear ThermometerYHT208YHT2080012026-05-07
06933257931213YUWELL® Infrared Ear ThermometerYHT202YHT2020012026-05-07
06933257931244YUWELL® Infrared Ear ThermometerYHT108YHT1080022026-05-07
06933257931251YUWELL® Infrared Ear ThermometerYHT202YHT2020022026-05-07
06933257931268YUWELL® Infrared Ear ThermometerYHT208YHT2080022026-05-07
06933257922006YUWELL® Finger Pulse OximeterYX1102026-05-06
06933257922013YUWELL® Finger Pulse OximeterYX3102026-05-06
06933257923171YUWELL® Finger Pulse OximeterYX1052026-05-06
06933257923188YUWELL® Finger Pulse OximeterYX1062026-05-06
06933257948488YUWELL Portable Oxygen ConcentratorSP-32026-02-24
06933257923133YUWELL® Infrared Ear ThermometerYHT1002025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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06933257931688YUWELL 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
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