Product code OAC— Cardiovascular

BOD POD

Classification name: Plethysmograph, Air Displacement For Body Composition Analysis
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Total cleared: 3
First cleared: 1995-02-13
Most recent: 2006-06-27

FDA classification definition

“To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).”
— U.S. Food and Drug Administration, device classification record for product code OAC under 21 CFR 870.2770, via openFDA

Market context for product code OAC

FDA has cleared 3 devices under product code OAC between 1995 and 2006, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20061 clearance
20041 clearance
19951 clearance

Top applicants under product code OAC

Life Measurement, Inc.2 clearances
Life Measurement Instruments, Inc.1 clearance

Recent clearances under product code OAC

K060848 — BOD PODLife Measurement, Inc.·2006-06-27
K032610 — MODIFIED SONAMET BODY COMPOSITION ANALYZERLife Measurement, Inc.·2004-03-01
K924972 — SONAMET BODY COMPOSITION ANALYZERLife Measurement Instruments, Inc.·1995-02-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.