FDA.reportPublic FDA data

ziqing

Primary DI
06974560230655
Brand
ziqing
Company
Shenzhen Ziqing Medical Equipment Co.,Ltd.
Model
XW-05
Catalog number
XW-05
Device description
Wrist electronic blood pressure monitor intended to measure systolic blood pressure, diastolic blood pressure, and pulse rate in adults (18 years and above). The device utilizes the oscillometric measurement method, automatically inflating and pressurizing the cuff to detect blood flow in the wrist arteries and converting it into digital readings. Designed for simple and convenient operation, it is suitable for non-invasive auxiliary monitoring in home and medical environments. Key features include an LED screen display, touch controls, 2x90 user memory storage with average calculation, WHO blood pressure classification indication, voice broadcast, and a built-in rechargeable lithium battery (DC 3.7V, 300mAh).
Published
2026-10-14
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
K253126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253126000Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.2026-06-18DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974560230655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974560230655069745602306556974560230655

Regulatory Flags#

DUNS number
713519612
Device count
1
DM exempt
false
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
06974560230648ziqingXB-01XB-012026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970331860779blood pressure monitorShenzhen Ruiankang Technology Co. Ltd.DXN2026-11-04
06927709405452AmetmedShenzhen Jamr Technology Co., Ltd.DXN2026-11-03
00841709121746MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONDXN2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONDXN2026-10-30
00850070979405FondCircleFondCircle Inc.DXN2026-10-21
00850070979412FondCircleFondCircle Inc.DXN2026-10-21
08719327007136FinapresFinapres Medical Systems B.V.DXN2026-10-21
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
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
06973826012257AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012264AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012271AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012288AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012295AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
06973826012301AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09