Bod Pod

FDA 510(k) K060848 · Life Measurement, Inc.

Substantially Equivalent

510(k) numberK060848

Submission

Device name
Bod Pod
Applicant
Life Measurement, Inc.
Concord, CA, US
Received
March 28, 2006
Decision date
June 27, 2006
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAC – Plethysmograph, Air Displacement For Body Composition Analysis
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).

Other 510(k)s with product code OAC

510(k)DeviceApplicantDecision
K032610Modified Sonamet Body Composition AnalyzerOAC · Abbreviated Life Measurement, Inc.03/01/2004SE
K924972Sonamet Body Composition AnalyzerOAC · Traditional Life Measurement Instruments, Inc.02/13/1995SE

More from Life Measurement Instruments, Inc.

510(k)DeviceDecision
K032610Modified Sonamet Body Composition AnalyzerOAC · Abbreviated 03/01/2004SE

Questions and answers

When was Bod Pod cleared by the FDA?

Bod Pod (K060848) received a 510(k) decision of Substantially Equivalent on June 27, 2006, 91 days after the submission was received.

What is the product code of K060848?

The FDA product code is OAC – Plethysmograph, Air Displacement For Body Composition Analysis, a Class II (moderate risk) device regulated under 21 CFR 870.2770.