FDA.reportPublic FDA data

ADKING

Primary DI
06977239080018
Brand
ADKING
Company
ShenZhen GoodlyMed Technology Co.,Ltd.
Model
A01-BL
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K241129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241129000Upper Arm Electronic Blood Pressure MonitorShenzhen Goodlymed Technology Co., Ltd.2024-07-03DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16977239080015PackageGS124In Commercial Distribution
06977239080018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697723908001516977239080015
06977239080018069772390800186977239080018

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
699346365
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977239080292MEMASAA01-SLB2025-06-01
06977239080308LIVAROCIA01-SLB2025-06-01
06977239080315AonedayA02-SE2025-06-01
16977239080299MEMASAA01-SLB2025-06-01
16977239080305LIVAROCIA01-SLB2025-06-01
16977239080312AonedayA02-SE2025-06-01
06977239080261AaotoA02-SE2025-04-30
16977239080268AaotoA02-SE2025-04-30
06977239080285LIVAROCIA012025-04-25
16977239080282LIVAROCIA012025-04-25
06977239080131AsnaghiA02-E2025-04-01
16977239080138AsnaghiA02-E2025-04-01
06977239080117N/AA01-BS2025-03-21
16977239080114N/AA01-BS2025-03-21
06977239080063AndesfitA02-SEB2025-01-14
06977239080087CHANIA02-BE2025-01-14
16977239080060AndesfitA02-SEB2025-01-14
16977239080084CHANIA02-BE2025-01-14
06977239080070FIYESA02-E2025-01-01
16977239080077FIYESA02-E2025-01-01

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