FDA.reportPublic FDA data

Higi Green (KMY)

Primary DI
B416KMY8202F0
Brand
Higi Green (KMY)
Company
HIGI SH LLC
Model
KMY-120630950-117
Catalog number
n/a
Device description
The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
Published
2018-09-20
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
K151127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151127000higi StationHigi Sh, LLC2015-12-08DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B416KMY8202F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, non-portableAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079773850
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B146ZT2776A00210higi SZZTZT2776A0021n/a2018-09-20
B416SH650Higi White1301252105n/a2018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00845717012171TrackstarVERIDIAN HEALTHCARE LLCDXN2026-05-28
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B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DXN2026-05-27