HIGI SH LLC

Address:100 South Wacker Drive , Suite 1600,Chicago,IL,60606,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (3)

Premarket Exempt

Clear

higi SZZT - B146ZT2776A00210 Catalog Number : n/a

Device Description : The higi Station is intended for use by the general public to measure blood pres 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.

Device Class : 2

Duns Number: 079773850

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Higi Green (KMY) - B416KMY8202F0 Catalog Number : n/a

Device Class : 2

Duns Number: 079773850

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

Higi White - B416SH650 Catalog Number : n/a

Device Class : 2

Duns Number: 079773850

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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