Wello, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
1
Total
1
Cleared
0
Denied
Wello, Inc. is a Texas-based medical device company specializing in precision temperature health systems. Designed and manufactured in Addison, the company develops innovative infection control solutions for healthcare facilities, manufacturing plants, and other industries. Wello's technology detects potential disease spreaders early, before symptoms appear.
The company has received 1 FDA 510(k) clearance from 1 total submission. Its cleared device falls within the General Hospital category. The company's regulatory clearance was granted in 2018. Wello is currently inactive, with no new clearances in more than five years, and should be treated as a historical regulatory record.
The welloStationX system represents the company's core offering-an FDA-cleared kiosk combining hardware and AI-powered software for workplace temperature screening. The platform identifies elevated temperature events and provides decision support to prevent infectious disease spread in real-time.
Explore the device clearance details, product codes, and submission dates in the 510(k) database.
510(k) submissions have been managed by Ken Block Consulting as regulatory consultant.
FDA 510(k) Regulatory Record - Wello, Inc.
1 devices