OMV

Ultrasonic Body Composition Analyzer

Product code

OMV

Device name

Ultrasonic Body Composition Analyzer

Device class

Class 2

21 CFR

21 CFR 870.2770

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).