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Adjunct Monitor, Protein Calorie Malnutrition

Page Type
Product Code
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 and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2770 Impedance plethysmograph

§ 870.2770 Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

Adjunct Monitor, Protein Calorie Malnutrition

Page Type
Product Code
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 and Urology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.2770 Impedance plethysmograph

§ 870.2770 Impedance plethysmograph.

(a) Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.

(b) Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]