FDA.reportPublic FDA data

DALTON BLOOD PRESSURE MONITOR

Primary DI
00815027010006
Brand
DALTON BLOOD PRESSURE MONITOR
Company
DALTON MEDICAL CORPORATION
Model
BPM-DI2003R
Device description
NON-INVASIVE BLOOD PRESSURE MONITOR, WRIST TYPE.
Published
2016-09-18
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
K062893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062893000KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003AShanghai Kodea Economic and Trade Development , Ltd.2007-02-05DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815027010006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815027010006008150270100068150270100060815027010006

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
874709348
Device count
1
HCT/P
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDBED42002026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDBED48002026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDBED54002026-02-27
00815027011867DALTON ROLLATOR AR-8411KDAR2025-10-28
00815027011881DALTON ROLLATOR AR-8411KDBL2025-10-28
00815027012871DALTON LOW AIR LOSS MATTRESS SYSTEMPM-XCEL5000TURN2025-10-28
00815027012888DALTON ROLLATOR AR-56430KDAR2025-10-28
00815027012703DALTON TRANSFER BENCHTB-5058-12025-09-18
00815027012741DALTON QUAD CANEA-QC4011SBK-42025-09-18
00815027012758DALTON TRANSFER BENCHTB-5006KDHD-22025-09-18
00815027012765DALTON SHOWER BENCHBS-5013A-22025-09-18
00815027012772DALTON YOUTH WALKERA-WA6107W-22025-09-18
00815027012789DALTON WALKER A-WA6006HD-22025-09-18
00815027012796DALTON WALKER A-WA6005HEM2025-09-18
00815027012819DALTON WALKER PLATFORMA-WPA6401-22025-09-18
00815027012826DALTON COMMODE CHAIRCOM-DA500-22025-09-18
00815027012833DALTON COMMODE CHAIRCOM-DA300-22025-09-18
00815027012840DALTON TOILET SEATBS-30271G-12025-09-18
00815027012864DALTON SHOWER BENCHBS-5004-42025-09-18
00815027012734DALTON OVERBED TABLEB-T3616ABS2025-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932825306057CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
06932825306064CareSimpleGuangdong Transtek Medical Electronics Co.,LtdDXN2026-07-21
00073796318321WIDE-RANGE D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00073796392437SMALL D-RING CUFFOmron Healthcare, Inc.DXN2026-07-20
00816042016516FORAFORA CARE INC.DXN2026-07-20
00898939002758FORAFORA CARE INC.DXN2026-07-20
06953825911515N/AShenzhen Urion Technology Co., LtdDXN2026-07-16
00850044118670iHealthiHealth Labs Inc.DXN2026-07-14
00850044118687iHealthiHealth Labs Inc.DXN2026-07-14
00850078377234iHealthiHealth Labs Inc.DXN2026-07-14
06953825911416N/AShenzhen Urion Technology Co., LtdDXN2026-07-13
00845717011556N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
00845717011563N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040112842N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040113481N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114358N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040114365N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06972040117397N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
MHC18602130N/AShenzhen AOJ Medical Technology Co., LtdDXN2026-07-11
06953825911294N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911300N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911317AlphamedShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911355N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
06953825911393N/AShenzhen Urion Technology Co., LtdDXN2026-07-09
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDXN2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDXN2026-07-07
06927709404608JALIPShenzhen Jamr Technology Co., Ltd.DXN2026-07-06
06927709404622WellWinkShenzhen Jamr Technology Co., Ltd.DXN2026-07-06