FDA.reportPublic FDA data

InBody

Primary DI
08809209590846
Brand
InBody
Company
InBody Co., Ltd.
Model
InBody970
Device description
Body composition analyzer which is not intended to diagnose or treat any medical condition.
Published
2022-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809209590846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809209590846088092095908468809209590846

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688003404
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809209592321InBodyInBody2802026-02-28
08809209592253InBodyInBody970S2025-10-03
08809209592260InBodyInBody3802025-10-03
08809209592277InBodyInBody5802025-10-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030024921seca analytics 125seca GmbH & Co. KGPUH2026-06-02
06932825306118TeleRPMGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
06932825306125PulseGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
00810140063007RENPHOJoicom CorporationPUH2026-04-20
00810140062994RENPHOJoicom CorporationPUH2026-04-08
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16977035520180ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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00810140062901RENPHOJoicom CorporationPUH2026-01-04