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U.S. Department of Health and Human Services

Product Classification

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Device ultrasonic body composition analyzer
Regulation Description Impedance plethysmograph.
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/Urology
Product CodeOMV
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type 510(k)
Regulation Number 870.2770
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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