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510(k) Data Aggregation
K Number
K172739Device Name
higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
Manufacturer
Date Cleared
2017-10-10
(28 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
higi SH LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, percent lean body mass, percent body fat, 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 also choose to store or send the data to a personal physician or healthcare professional.
Device Description
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K Number
K151127Device Name
higi Station
Manufacturer
Date Cleared
2015-12-08
(224 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
higi SH LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The higi Station is intended to be used by the general public to measure blood pressure, pulse, body weight, 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 also choose to store or send the data to a personal physician or healthcare professional. The user has to be at least 13 years old.
Device Description
Not Found
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