Data / Medical devices / United States / ZYTO Technologies, Inc.
ZYTO Technologies, Inc.: FDA-registered device maker in Lehi, UT, United States, 1 510(k) clearance
ZYTO Technologies, Inc. is registered with the FDA (registration 3008493238) in Lehi, UT, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 30, 2011. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008493238
- Address
- 1401 N. Thanksgiving Way STE 325, Lehi, UT, United States, 84048
- Owner or operator
- ZYTO Technologies, Inc. (10043910)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 4, 2013
- Registered through
- 2026
- Brand names listed
- ZYTO Hand Cradle, ZYTO Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Galvanic Skin Response Measurement | GZO | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 30, 2011 | K111308 | ZYTO HAND CRADLE | GZO | Substantially Equivalent | Zyto Technologies, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 23, 2015 | 74273 | Class II | Terminated | The ZYTO Tower is the input device to program the software with various virtual items. | ZYTO Technologies Inc. Announces a Voluntary Recall of the ZYTO Tower and ZYTO Select and Elite Software Due to Claims Exceeding the 510(k) Clearance. | accessdata.fda.gov |
Compare with other makers
Updated August 30, 2011. 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.