FDA.reportPublic FDA data

Pylo Health

Primary DI
00860004709565
Brand
Pylo Health
Company
Prevounce Health, Inc
Model
802-LTE
Device description
Cellular connected (LTE-M and GPRS) non-invasive blood pressure monitor.
Published
2022-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202891000Blood Pressure MonitorGuangdong Transtek Medical Electronics Co., Ltd.2021-03-09DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860004709507PackageGS110In Commercial Distribution
00860004709565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086000470950720860004709507
00860004709565008600047095658600047095650860004709565

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Regulatory Flags#

DUNS number
116961530
Device count
1
Serial number
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
00860004709510Pylo Health300-LTE2021-01-11
00860004709527Pylo Health1775-N2021-02-24
00860004709534Pylo Health802-LTE2021-06-07
00860004709572Pylo Health200-LTE2023-03-15
00860004709503Pylo HealthPY-802-LTE2020-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06977093190052NAGuangdong Xinyu Electronic and Technology Co., Ltd.DXN2026-06-01
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