Product Classification

• Device: plethysmograph, air displacement for body composition analysis
• Regulation Description: Impedance plethysmograph.
• 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: Obstetrics/Gynecology
• Product Code: OAC
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: 510(k)
• Regulation Number: 870.2770
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc