Data / Medical devices / United States / Iotamotion, Inc.
Iotamotion, Inc.: FDA-registered device maker in Vadnais Heights, MN, United States, 1 510(k) clearance
Iotamotion, Inc. is registered with the FDA (registration 3030411493) in Vadnais Heights, MN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 1, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030411493
- Address
- 4205 White Bear Pkwy Ste 600, Vadnais Heights, MN, United States, 55110
- Owner or operator
- iotaMotion, Inc. (10083773)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 17, 2021
- Registered through
- 2026
- Brand names listed
- iotaSOFT Insertion System - Drive Unit, Controller and Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Insertion System For A Cochlear Implant Electrode Array | QQH | 2 | 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 |
|---|---|---|---|---|---|---|
| October 1, 2021 | DEN190055 | iotaSOFT Insertion System - Drive Unit, Controller and Accessories | QQH | Unknown | Iotamotion, 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 |
|---|---|---|---|---|---|---|
| September 12, 2024 | 95462 | Class III | Completed | iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of impla | Incorrect GTIN number. | accessdata.fda.gov |
Compare with other makers
Updated November 1, 2024. 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.