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U.S. Department of Health and Human Services

Product Classification

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Device adjunct monitor, protein calorie malnutrition
Regulation Description Impedance plethysmograph.
Definition Device applies an alternating current of one specified frequency or more through skin-surface electrodes to estimate one or more the body composition parameters.
Physical State Electronic black box/monitor with keypad or other interface and display having the ability to connect to four electrodes and computer.
Technical Method Applying a small electrical alternating current of one or more frequencies to living tissue, the device measures current (I), voltage (V) and phase angle (Phi) response, and from these values, calculates resistance (R), reactance (Xc), and impedance (Z), which are used to further calculate estimated body composition parameters via empirical algorithms.
Target Area Although the device is connected at different locations of the subject’s skin such as the palms of each hand and the soles of each foot, the signal is distributed through the entire body.
Regulation Medical Specialty Cardiovascular
Review Panel Gastroenterology/Urology
Product CodeQJB
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 870.2770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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