Company profile

Prolaio, Inc.

Prolaio, Inc. has 1 AI-enabled medical device on the FDA list. The first decision was on December 16, 2025 and the most recent on December 16, 2025 (prolaio eVO2peak Module (Version 1.0)). Its most common review panel is Cardiovascular (1 device).

1AI devices

2025First decision

2025Latest decision

1Specialties

Timeline

December 16, 2025 · 510(k) K252204prolaio eVO2peak Module (Version 1.0) · Cardiovascular · PPW