FDA.reportPublic FDA data

BodyTrace

Primary DI
B726BT0060
Brand
BodyTrace
Company
BODYTRACE, INC
Model
BT006
Device description
Weight scale.
Published
2021-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B726BT0061PackageHIBCC1In Commercial Distribution
B726BT0062PackageHIBCC5In Commercial Distribution
B726BT0060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal105 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure80 KiloPascal105 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Regulatory Flags#

DUNS number
116841525
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B726BT007A0BodyTraceBT007A2025-03-14
B726BT007B0BodyTraceBT007B2025-03-14
B726BT007A1BodyTraceBT007A2025-03-14
B726BT007B1BodyTraceBT007B2025-03-14
B726BT1060BodyTraceBT1062021-11-03
B726BT0061BodyTraceBT0062021-11-03
B726BT1061BodyTraceBT1062021-11-03
B726BT0050BodyTraceBT0052020-07-06
B726BT005O0OmadaBT0052020-07-06
B726BT005V0VidaBT0052020-07-06
B726BT0051BodyTraceBT0052020-07-06
B726BT005O1OmadaBT0052020-07-06
B726BT005V1VidaBT0052020-07-06
B726BT1050BodyTraceBT1052020-06-23
B726BT105O0OmadaBT105O2020-06-23
B726BT1051BodyTraceBT1052020-06-23
B726BT105O1OmadaBT105O2020-06-23
B726BT1040BodyTraceBT1042019-04-01
B726BT104O0OmadaBT104O2019-04-01
B726BT1042BodyTraceBT1042019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719846009455CharderCHARDER ELECTRONIC CO., LTD.FRI2026-04-29
04719846017115CharderCHARDER ELECTRONIC CO., LTD.FRI2026-03-27
00810079260003Teladoc Health, Inc.Teladoc Health, Inc.FRI2026-02-17
00850068074310TenoviTenovi Co.FRI2025-11-20
00850068074389TenoviTenovi Co.FRI2025-11-20
00850068074471TenoviTenovi Co.FRI2025-11-20
04719846016699CharderCHARDER ELECTRONIC CO., LTD.FRI2025-11-13
00850033352191Dario Smart Scale (Cellular)- Wight Management SystemDARIOHEALTH CORP.FRI2025-10-15
00810079260010Teladoc Health, Inc.Teladoc Health, Inc.FRI2025-09-22
00845717011785R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-08
00845717011068R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717011938R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717012102TrackstarVERIDIAN HEALTHCARE LLCFRI2025-09-02
00845717012195TrackstarVERIDIAN HEALTHCARE LLCFRI2025-09-02
04012030022774seca 286seca GmbH & Co. KGFRI2025-08-08
04012030022682seca 284seca GmbH & Co. KGFRI2025-08-07
04012030022699seca 284seca GmbH & Co. KGFRI2025-08-07
04012030022705seca 284seca GmbH & Co. KGFRI2025-08-07
00860013816506Empo FootprintEmpo Health, Inc.FRI2025-07-31
06970729040202CADENCEZhongshan Transtek Electronics Co.,LtdFRI2025-07-21
04012030022637seca 264seca GmbH & Co. KGFRI2025-06-02
04012030022668seca 274seca GmbH & Co. KGFRI2025-06-02
B726BT007A0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007A1BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B1BodyTraceBODYTRACE, INCFRI2025-03-14
06970729040080TeleRPM™Zhongshan Transtek Electronics Co.,LtdFRI2025-02-06
00850070979108FondCircleFondCircle Inc.FRI2025-01-14
00093764604140A&D MedicalA&D COMPANY, LIMITEDFRI2024-10-18
00093764604546A&D MedicalA&D COMPANY, LIMITEDFRI2024-10-18