FDA.reportPublic FDA data

prolaio eVO2peak Module

Primary DI
00850071330144
Brand
prolaio eVO2peak Module
Company
Prolaio, Inc.
Model
1.0
Device description
prolaio eVO2peak 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
PPWAdjunctive Cardiovascular Status Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPWAdjunctive Cardiovascular Status IndicatorCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252204000prolaio eVO2peak Module (Version 1.0)Prolaio, Inc.2025-12-16PPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071330144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071330144008500713301448500713301440850071330144

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
8558699054support@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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863061000316T3 PLATFORM SOFTWAREETIOMETRY INC.PPW2026-03-17
00863061000323ETIOMETRY PLATFORMETIOMETRY INC.PPW2026-03-17
00860003025628Compensatory Reserve Tablet T1 V2021.03.01FLASHBACK TECHNOLOGIES, INC.PPW2021-04-12
00860003025604CipherOx CRIFLASHBACK TECHNOLOGIES, INC.PPW2020-05-19
00860003025611Compensatory Reserve Tablet T1 V2020.04.22FLASHBACK TECHNOLOGIES, INC.PPW2020-05-19
00863061000309T3 Risk Analytics PlatformETIOMETRY INC.PPW2016-09-09