FDA.reportPublic FDA data

PROLAIO INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30305977233030597723PROLAIO INC.1N2026-01-01230 W Monroe St Ste 2560 Chicago IL US 60606

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850071330052prolaio Heart Rhythm Module - 1.0855-869-9054support@prolaio.com
00850071330083prolaio Convenience Kit - prolaio Convenience Kit - Model F855-869-9054support@prolaio.com
00850071330106prolaio Convenience Kit - prolaio Convenience Kit - Model A855-869-9054support@prolaio.com
00850071330113prolaio Convenience Kit - prolaio Convenience Kit - Model E855-869-9054support@prolaio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3265111339496569K252204prolaio eVO2peak Module (Version 1.0)PPW2025-12-16
3265111603779413K193415physIQ Heart Rhythm and Respiration ModuleDPS2020-06-11
3265112065840080K183322physIQ Heart Rhythm and Respiratory ModuleDPS2019-07-10
3265111107574287K180234physiQ Heart Rhythm ModuleDPS2018-08-10
3265111173002840K142512Personalized Physiology Analytics Engine softwarePLB2015-06-11
3265111857742804

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DPS32020-06-11
PPW12025-12-16
PLB12015-06-11

GUDID#