FDA.reportPublic FDA data

prolaio Personalized Physiology Analytics Engine Software (PPA)

Primary DI
00850071330038
Brand
prolaio Personalized Physiology Analytics Engine Software (PPA)
Company
Prolaio, Inc.
Model
1.0
Device description
prolaio Personalized Physiology Analytics Engine Software
Published
2025-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLBMultivariate Vital Signs Index

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLBMultivariate Vital Signs IndexCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142512000Personalized Physiology Analytics Engine softwareVgbio, Inc (Dba Physiq)2015-06-11PLB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071330038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071330038008500713300388500713300380850071330038

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography monitoring system receiverAn electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-869-9054support@prolaio.com

Regulatory Flags#

DUNS number
118827870
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071330052prolaio Heart Rhythm Module1.02026-05-07
00850071330137prolaio Heart Rhythm and Respiration Module2.02026-05-07
00850071330144prolaio eVO2peak Module1.02026-05-07
00850071330007prolaio Mobile AppDP-22-062025-06-13
00850071330014prolaio CloudDP-21-032025-06-13
00850071330045prolaio Heart Rhythm and Respiration Module3.02025-06-13
00850071330069prolaio Convenience KitD2025-06-13
00850071330076prolaio Convenience KitC2025-06-13
00850071330083prolaio Convenience KitF2025-06-13
00850071330090prolaio Convenience KitB2025-06-13
00850071330106prolaio Convenience KitA2025-06-13
00850071330113prolaio Convenience KitE2025-06-13
00850071330120prolaio Convenience KitG2025-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350140270027NAVOYCDSAlgoDx ABPLB2026-05-13
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PLB2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PLB2026-03-17
08809957910002SpassageQSpass Co.,Ltd.PLB2023-06-27
08885018690021Biovitals Analytics EngineBIOFOURMIS SINGAPORE PTE. LTD.PLB2022-10-28
00860004366263physIQ Personalized Physiology Analytics EnginePHYSIQ, INCPLB2022-01-10
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PLB2016-09-09