WelloStationX
Thermometer, Electronic, Clinical
Wello, Inc
The following data is part of a premarket notification filed by Wello, Inc with the FDA for Wellostationx.
Pre-market Notification Details
| Device ID | K180298 |
| 510k Number | K180298 |
| Device Name: | WelloStationX |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Wello, Inc 3939 Belt Line Road, Suite 400 Addison, TX 75001 |
| Contact | Alan Camerik(rik) Heller |
| Correspondent | Alan C Heller Ken Block Consulting 3939 Belt Line Road, Suite 400 Addison, TX 75081 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-11-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011348603 | K180298 | 000 |
Trademark Results [WelloStationX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WELLOSTATIONX 88936983 not registered Live/Pending |
Wello, Inc. 2020-05-28 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.