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Plethysmograph, Air Displacement For Body Composition Analysis

Page Type
Product Code
Definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
Physical State
An air-tight, dual compartment fiberglass and plexiglas chamber that the subject enters
Technical Method
Uses Boyle's law in conjunction with the two precisely-sized compartments to determine the volume occupied by the subject's body. Average total body density is calculated from the weight and volume determined by the device. Empirical equations, as a function of density of known tissue types, are then used to estimate body composition parameters.
Target Area
whole body
Regulation Medical Specialty
Cardiovascular
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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]

Plethysmograph, Air Displacement For Body Composition Analysis

Page Type
Product Code
Definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
Physical State
An air-tight, dual compartment fiberglass and plexiglas chamber that the subject enters
Technical Method
Uses Boyle's law in conjunction with the two precisely-sized compartments to determine the volume occupied by the subject's body. Average total body density is calculated from the weight and volume determined by the device. Empirical equations, as a function of density of known tissue types, are then used to estimate body composition parameters.
Target Area
whole body
Regulation Medical Specialty
Cardiovascular
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
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]