FDA.reportPublic FDA data

InBody

Primary DI
08809209592277
Brand
InBody
Company
InBody Co., Ltd.
Model
InBody580
Device description
Body Composition Analyzer
Published
2025-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141483000BIOSPACE BODY COMPOSITION ANALYZERBiospace Corporation Limited2014-09-23MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809209592277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809209592277088092095922778809209592277

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
323-932-6503info@inbodyusa.com

Regulatory Flags#

DUNS number
688003404
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809209592321InBodyInBody2802026-02-28
08809209592253InBodyInBody970S2025-10-03
08809209592260InBodyInBody3802025-10-03
08809209590280InBodyInBodyH20B2018-05-17
08809209590969InBodyInBodyM202024-07-23
08809209590938InBodyFRA510(s)2023-06-22
08809209590976InBodyBWAON2023-06-22
08809209591676InBodyInBody3802023-06-22
08809209591683InBodyInBody5802023-06-22
08809209590877InBodyBWA2.02022-07-25
08809209591980InBodyInGrip(IB-HGSm)2025-05-09
08809209591881InBodyInBody270S2024-07-15
08809209591898InBodyInBody770S2024-07-15
08809209591904InBodyInBody970S2024-07-15
08809209591911InBodyBWA2.0S2024-07-15
08809209590945InBodyIB-LS2023-06-22
08809209591362InBodyLookinBody 1202023-06-22
08809209591379InBodyLookinBody M202023-06-22
08809209591386InBodyLookinBody Web2023-06-22
08809209590563InBodyBP1702022-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04904785198449Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
04904785230491Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
08809209592260InBodyInBody Co., Ltd.MNW2025-10-03
00077784049198TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
08809209590969InBodyInBody Co., Ltd.MNW2024-07-23
00074108499714ConairCONAIR CORPORATIONMNW2024-05-13
B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
00875011004121Weight GurusGreater GoodsMNW2024-02-22
00074108356581CONAIRCONAIR CORPORATIONMNW2024-01-15
00074108451200CONAIRCONAIR CORPORATIONMNW2023-07-17
00074108453457CONAIRCONAIR CORPORATIONMNW2023-07-17
00074108458995CONAIRCONAIR CORPORATIONMNW2023-07-17
00074108483553CONAIRCONAIR CORPORATIONMNW2023-06-24
08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
08809209591676InBodyInBody Co., Ltd.MNW2023-06-22
08809209591683InBodyInBody Co., Ltd.MNW2023-06-22
00074108087799CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108122728CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108186751CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108199256CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108278197CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108288493CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108317216CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108333025CONAIRCONAIR CORPORATIONMNW2023-04-30
00694501121786SunbeamStar Elite IncMNW2023-01-17
00074108278043Conair CONAIR CORPORATIONMNW2022-12-05
00074108313874CONAIRCONAIR CORPORATIONMNW2022-11-28
00074108468451CONAIRCONAIR CORPORATIONMNW2022-07-28
00077784043073TaylorTAYLOR PRECISION PRODUCTS, INC.MNW2022-07-08