FDA.reportPublic FDA data

prolaio Heart Rhythm and Respiration Module

Primary DI
00850071330137
Brand
prolaio Heart Rhythm and Respiration Module
Company
Prolaio, Inc.
Model
2.0
Device description
prolaio Heart Rhythm and Respiration Module
Published
2026-05-07
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
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183322000physIQ Heart Rhythm and Respiratory ModulePhysiq, Inc.2019-07-10DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071330137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071330137008500713301378500713301370850071330137

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).

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
00850071330144prolaio eVO2peak Module1.02026-05-07
00850071330007prolaio Mobile AppDP-22-062025-06-13
00850071330014prolaio CloudDP-21-032025-06-13
00850071330038prolaio Personalized Physiology Analytics Engine Software (PPA)1.02025-06-13
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

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