FDA.reportPublic FDA data

Oklar

Primary DI
06927709404387
Brand
Oklar
Company
Shenzhen Jamr Technology Co., Ltd.
Model
B19T
Published
2026-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K233146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233146000Blood Pressure MonitorShenzhen Jamr Technology Co., Ltd.2024-03-19DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16927709404384PackageGS130In Commercial Distribution
06927709404387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692770940438416927709404384
06927709404387069277094043876927709404387

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
421350239
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06927709421025CIEKAAB21H2021-08-27
06927709404608JALIPW20L2026-07-06
06927709404622WellWinkC06T2026-07-06
06927709404394OklarW1101L2026-04-25
06927709404400OklarW1101L2026-04-25
06927709404417OklarW1101L2026-04-25
06927709404424OklarW1101L2026-04-25
06927709404431DOUHAOC022026-04-25
06927709404448OklarC022026-04-25
06927709404462OklarC022026-04-25
06927709404479OklarC022026-04-25
06927709404486OklarC022026-04-25
06927709404332WishloveC03A2026-04-15
06927709404349WishloveC03A2026-04-15
00370393005693VERSAC022020-10-12
00856471007228AlcedoB232020-10-12
00860002249629RENPHOB022019-12-12
06927709400051LazleF012021-05-28
06927709401355perbeat B012019-03-04
06927709401379N/AB232025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01