Cardiology
prolaio eVO2peak Module (Version 1.0)
Prolaio, Inc.
FDA-cleared AI medical device
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
FDA Submission Metadata
- Submission number
- K252204
- Decision date
- December 2025
- FDA panel
- Cardiovascular
- Product code
- PPW
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.