FDA.reportPublic FDA data

Fitreno

Primary DI
16927709442157
Brand
Fitreno
Company
Shenzhen Jamr Medical Technology Co., Ltd.
Model
B22
Published
2020-09-07
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
K172171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172171000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16927709442157PackageGS130In Commercial Distribution
06927709442150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1692770944215716927709442157
06927709442150069277094421506927709442150

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
421350239
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
16927709404278MevitaBE212026-03-19
16927709404100OklarB19T2025-12-31
16927709400034OklarB19T2025-12-22
16978034830133tenoviCuff 15-28CM2025-12-12
16978034830140tenoviCuff 32-52CM2025-12-12
16927709404087Ease HealthcareW1104L2025-11-27
16927709404094Ease HealthcareB21HT2025-11-27
16927709403417ASTARTW20L2025-07-28
16927709403424AbeseeB23M2025-07-28
16927709403431FOTOSYW022025-07-28
16927709403448NOUYANBA31T2025-07-28
16927709403455OklarC02T2025-07-28
16927709403462meteneB13A2025-07-28
16927709403295OklarB23M2025-06-25
16927709403318ON THE GO MEDICAL SUPPLYF1701T2025-06-25
16927709403325ON THE GO MEDICAL SUPPLYBC31LT2025-06-25
16927709401376N/AB232025-03-07
16927709401574OklarW062025-03-07
16927709401819OklarW052025-03-07
16927709401918N/AB232025-03-07

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