Data / Medical devices / United States / Ultrathera Technologies, Inc.
Ultrathera Technologies, Inc.: FDA-registered device maker in Colorado Springs, CO, United States, 1 510(k) clearance
Ultrathera Technologies, Inc. is registered with the FDA (registration 3027406982) in Colorado Springs, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027406982
- Address
- 2 N Cascade Avenue Suite 1320, Colorado Springs, CO, United States, 80903
- Owner or operator
- UltraThera Technologies, Inc. (10088173)
- Roles
- Manufacturer
- First device listed
- June 6, 2023
- Registered through
- 2026
- Brand names listed
- GyroStim
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Vestibular Analysis | LXV | U | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 27, 2022 | K220231 | GyroStim | LXV | Substantially Equivalent | Ultrathera Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 27, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.