FDA.reportPublic FDA data

Pylo Health

Primary DI
10860004709517
Brand
Pylo Health
Company
PREVOUNCE HEALTH, LLC
Model
300-LTE
Device description
Cellular connected (LTE) body weight scale for remote patient monitoring.
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116961530
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20860004709507Pylo Health802-LTE2022-06-28
10860004709531Pylo Health802-LTE2021-06-07
10860004709524Pylo Health1775-N2021-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987001125SR ScalesS R INSTRUMENTS, INC.FRI2026-06-08
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.FRI2026-06-02
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