FDA.reportPublic FDA data

iHealth

Primary DI
10856362005392
Brand
iHealth
Company
IHEALTH LAB INC.
Model
KN-550BT
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K160014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160014000iHealth Track Blood Pressure MonitorAndon Health Co, Ltd.2016-02-02DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856362005392PackageGS112In Commercial Distribution
00856362005395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085636200539210856362005392
00856362005395008563620053958563620053950856362005395

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive blood pressure physical simulatorAn instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054953337
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
10850044118691iHealthPT2L2025-12-19
10850044118707iHealthPT9L2025-12-19
10850044118721iHealthPT9L2025-12-19
10850044118776iHealthBG5S2025-12-19
10850044118806iHealthAG-6072025-12-19
10850078377088iHealthKN-550BT2025-12-19
10856362005156iHealthBG5SKIT2025-12-19
10850044118967iHealthBP-300CL2025-12-10
10856362005149iHealthBP5S2025-03-03
10850044118844iHealth3.6g*902024-11-18
10850044118868iHealthANC12024-10-30
10850044118783iHealthF50432024-09-28
10850044118233iHealthBG5SKIT2024-05-28
10850044118240iHealthBG5SKIT2024-05-27
10850044118424iHealthICF-30002024-05-25
10850044118431iHealthICF-30002024-05-24
10850044118455iHealthICF-30002024-05-24
10850044118257iHealthEGS-20032023-08-30
10850044118264iHealthEGS-20032023-08-30
10850044118202iHealthEGS-20032023-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06973912940419IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06973912940426IMDKShenzhen IMDK Medical Technology Co., LtdDXN2026-06-23
06926347900497POSTUREShenzhen Brav Electronic Technologies Co., Ltd.DXN2026-06-09
06953825911041ELERAShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911188sakerplusShenzhen Urion Technology Co., LtdDXN2026-06-03
06953825911218AlphamedShenzhen Urion Technology Co., LtdDXN2026-06-03