GyroStim
Apparatus, Vestibular Analysis
UltraThera Technologies, Inc.
The following data is part of a premarket notification filed by Ultrathera Technologies, Inc. with the FDA for Gyrostim.
Pre-market Notification Details
| Device ID | K220231 |
| 510k Number | K220231 |
| Device Name: | GyroStim |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | UltraThera Technologies, Inc. 2 North Cascade Avenue, Suite 640 Colorado Springs, CO 80903 |
| Contact | Kevin Maher |
| Correspondent | Kevin Maher UltraThera Technologies, Inc. 2 North Cascade Avenue, Suite 640 Colorado Springs, CO 80903 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-27 |
| Decision Date | 2022-04-27 |
Trademark Results [GyroStim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GYROSTIM 85631016 4271971 Live/Registered |
UltraThera Technologies, Inc. 2012-05-21 |
 GYROSTIM 85631012 4271970 Live/Registered |
UltraThera Technologies, Inc. 2012-05-21 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.