BOD POD® Body Composition System

Basic Information

• Brand Name: BOD POD® Body Composition System
• Primary DI: 00866203000205
• Version / Model: 2007A
• Company Name: COSMED USA, INC.
• Labeler DUNS: 020221102
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 4
• Public Version Date: 2020-10-21
• Public Version Status: Update
• Public Device Record Key: d753cd53-86ab-4f76-910e-348e1879d1a6

Device Description

The BOD POD® is indicated for measuring the body mass and estimating the body composition (i.e. percent and absolute amounts of fat and lean body mass) of generally healthy individuals. The BOD POD is also indicated for estimating Resting Metabolic Rate (RMR) and Total Energy Expenditure (TEE) in generally healthy individuals aged 18 years or older.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAC	Plethysmograph, Air Displacement For Body Composition Analysis	Cardiovascular	870.2770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64281	Densitometry body composition analyser	An electrically-powered stationary device intended to use whole-body densitometry to determine body composition (percent and absolute body fat, and fat-free mass) based on manually-entered subject demographic data (e.g., age, gender, height), body weight, and body volume. The system includes controls and display, a scale for body weight measurement, and a closable cabin-like chamber with pre-calibrated air pressure sensors for determining body volume using air displacement plethysmography (by the application of pressure-volume relationships).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00866203000205	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K060848	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 40 – 100 Degrees Fahrenheit