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510(k) Data Aggregation
K Number
K122076Device Name
PERSONAL HEALTH CENTER (PHC)
Manufacturer
Date Cleared
2013-04-15
(273 days)
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
ADFLOW HEALTH NETWORKS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ADFLOW Personal Health Center (PHC) is indicated for and consists of
- 1) A Blood Pressure Monitor (BPM) that is used for the measurement of blood pressure and heart rate by members of the general public. The device does not perform any diagnoses; it only provides blood pressure and heart rate data to the users, who are advised to consult a physician.
- 2) a Body Composition Monitor (BCM) that is used as a body fat analyzer that estimates the percent body fat (%BF), percent lean body mass (%LBM) and percent total body water (TBW%) with the use of BIA (bioelectrical impedance analysis).
The PHC is intended for healthy subjects between 8 and 92 years.
Device Description
The ADFLOW Personal Health Center (PHC) consists of a Blood Pressure Monitor (BPM) and a Body Composition Monitor (BCM). The BPM measures blood pressure and heart rate. The BCM estimates percent body fat, percent lean body mass, and percent total body water using bioelectrical impedance analysis (BIA).
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