FDA.reportPublic FDA data

Pylo Health

Primary DI
00860004709510
Brand
Pylo Health
Company
Prevounce Health, Inc
Model
300-LTE
Device description
Cellular connected (LTE) body weight scale for remote patient monitoring.
Published
2021-01-11
Public version status
Update
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
10860004709517PackageGS14In Commercial Distribution
00860004709510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000470951710860004709517
00860004709510008600047095108600047095100860004709510

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.

Regulatory Flags#

DUNS number
116961530
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
00860011521211Pylo HealthGL1-CTR2024-04-15
00860011521259Pylo HealthGLU-LTE2024-04-15
00860011521266Pylo HealthOX1-LTE2024-09-18
00860011521204Pylo HealthGL1-LTE2024-04-15
00860011521228Pylo HealthGL1-STP-502024-04-15
00860011521235Pylo HealthGL1-LCT2024-04-15
00860011521242Pylo HealthGL1-LCS-502024-04-15
00860004709596Pylo Health900-LTE2023-09-25
00860004709527Pylo Health1775-N2021-02-24
00860004709534Pylo Health802-LTE2021-06-07
00860004709565Pylo Health802-LTE2022-06-28
00860004709572Pylo Health200-LTE2023-03-15
00860004709503Pylo HealthPY-802-LTE2020-09-01

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