Data / Medical devices / United States / Prolaio Inc.
Prolaio Inc.: FDA-registered device maker in Chicago, IL, United States, 5 510(k) clearances
Prolaio Inc. is registered with the FDA (registration 3030597723) in Chicago, IL, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030597723
- Address
- 230 W Monroe St Ste 2560, Chicago, IL, United States, 60606
- Owner or operator
- Prolaio Inc. (10090226)
- Roles
- Manufacturer
- First device listed
- February 29, 2024
- Registered through
- 2026
- Brand names listed
- prolaio Heart Rhythm Module, prolaio Heart Rhythm and Respiration Module, prolaio Medical Device Data System Platform, prolaio Personalized Physiology Analytics Engine Software, prolaio eVO2peak Module (1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adjunctive Cardiovascular Status Indicator | PPW | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Multivariate Vital Signs Index | PLB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K252204 | prolaio eVO2peak Module (Version 1.0) | PPW | Substantially Equivalent | Prolaio, Inc. | accessdata.fda.gov |
| June 11, 2020 | K193415 | physIQ Heart Rhythm and Respiration Module | DPS | Substantially Equivalent | Physiq, Inc. | accessdata.fda.gov |
| July 10, 2019 | K183322 | physIQ Heart Rhythm and Respiratory Module | DPS | Substantially Equivalent | Physiq, Inc. | accessdata.fda.gov |
| August 10, 2018 | K180234 | physiQ Heart Rhythm Module | DPS | Substantially Equivalent | Physiq, Inc. | accessdata.fda.gov |
| June 11, 2015 | K142512 | Personalized Physiology Analytics Engine software | PLB | Substantially Equivalent | Vgbio, Inc (Dba Physiq) | accessdata.fda.gov |
Compare with other makers
- All makers of Electrocardiograph
- All makers of Adjunctive Cardiovascular Status Indicator
- All makers of Multivariate Vital Signs Index
- All makers of Medical Device Data System
Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.