FDA.reportPublic FDA data

IDEA Health

Primary DI
G057IDWS8090
Brand
IDEA Health
Company
IDEA HEALTH LLC
Model
ID-WS809
Published
2021-04-08
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
G057IDWS8091PackageHIBCC1In Commercial Distribution
G057IDWS8092PackageHIBCC4In Commercial Distribution
G057IDWS8090PrimaryHIBCC0

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 Pressure86 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
117854485
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G057IDBP8080IDEA HealthID-BP8082021-04-08
G057IDBP8081IDEA HealthID-BP8082021-04-08
G057IDWS8091IDEA HealthID-WS8092021-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987003761SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003778SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003785SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003792SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003808SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003815SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003822SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003839SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987000029SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000036SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000135SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000142SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000159SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000166SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000173SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000180SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000197SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000203SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000210SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000258SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000265SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000449SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000777SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000784SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000791SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000807SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001033SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001040SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001057SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001064SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23