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Ultrasonic Body Composition Analyzer

Page Type
Product Code
Definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.
Physical State
Hand-held cylindrical (or other shaped) electro/mechanical software-controlled device made of plastic and/or metal components and crystalline transducers.
Technical Method
Sends ultrasonic radiation produced by a piezoelectric crystal transmitter/transducer through body tissue at the site chosen and measures the speed of reflection at a piezoelectric receiver/transducer.
Target Area
Any external location on the skin or designated locations on the arm, leg, abdomen, chest, etc. that are required to validate the body composition algorithm used.
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
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]

Ultrasonic Body Composition Analyzer

Page Type
Product Code
Definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.
Physical State
Hand-held cylindrical (or other shaped) electro/mechanical software-controlled device made of plastic and/or metal components and crystalline transducers.
Technical Method
Sends ultrasonic radiation produced by a piezoelectric crystal transmitter/transducer through body tissue at the site chosen and measures the speed of reflection at a piezoelectric receiver/transducer.
Target Area
Any external location on the skin or designated locations on the arm, leg, abdomen, chest, etc. that are required to validate the body composition algorithm used.
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
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]