PEA POD Infant Body Composition System

Primary DI
00866203000243
Brand
PEA POD Infant Body Composition System
Company
COSMED USA, INC.
Model
PP2025
Device description
The PEA POD® Infant Body Composition System (“PEA 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 subjects between 1 and 8 kilograms. It is not intended for use with subjects requiring life support.
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
OACPlethysmograph, Air Displacement For Body Composition Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OACPlethysmograph, Air Displacement For Body Composition AnalysisCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032610000MODIFIED SONAMET BODY COMPOSITION ANALYZERLife Measurement, Inc.2004-03-01OAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866203000243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866203000243008662030002438662030002430866203000243

GMDN Terms#

Term, Definition table
TermDefinition
Densitometry body composition analyserAn 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-21 Degrees Celsius75 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
9256766002serviceusa@cosmed.com

Regulatory Flags#

DUNS number
020221102
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866203000236BOD POD® GS-X Body Composition System20202020-10-20
00866203000205BOD POD® Body Composition System2007A2016-09-21
00866203000212BOD POD® Body Composition System2007B2016-09-21
00866203000229PEA POD® Infant Body Composition SystemPEA POD Infant Body Composition System2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866203000236BOD POD® GS-X Body Composition SystemCOSMED USA, INC.OAC2020-10-20
00866203000229PEA POD® Infant Body Composition SystemCOSMED USA, INC.OAC2016-09-23
00866203000205BOD POD® Body Composition SystemCOSMED USA, INC.OAC2016-09-21
00866203000212BOD POD® Body Composition SystemCOSMED USA, INC.OAC2016-09-21