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Iotamotion, Inc.

United StatesFDA applicant, unverified FDA FEI 3030411493

Iotamotion, Inc. is a medical device manufacturer, with 8 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 1 FDA recall as of 15 Nov 2026.

Devices
8
Registrations
FDA
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 6
  • FDA 510(k) 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 8
FDA recalls
Identifiers
  • FDA FEI 3030411493
  • DUNS 080053045

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue8

Newest first, rows 1-8 of 8

Company details

FDA FEI number
3030411493
DUNS number
080053045
Address
4205 White Bear Pkwy Ste 600, Vadnais Heights, MN, 55110

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 12 Sep 2024 Z-0288-2025 Class III Completed Incorrect GTIN number. Distribution: Distribution was made to Iowa. There was no government/military/foreign distribution.

Frequently asked questions

How many devices does Iotamotion, Inc. have in the registry?

The registry currently lists 8 devices for Iotamotion, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Iotamotion, Inc.'s devices?

Among its 8 most recently registered devices, Iotamotion, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Iotamotion, Inc.'s devices fall under?

Among its 8 most recently registered devices, the classes recorded for Iotamotion, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Iotamotion, Inc.?

FDA recall records list 1 recall initiated by Iotamotion, Inc., the most recent initiated on 12 Sep 2024. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Iotamotion, Inc. in the registry?

The most recently registered devices listed for Iotamotion, Inc. include iotaSOFT Insertion System IM-05, iotaSOFT Insertion System IM-00, iotaSOFT Insertion System IM-04 and iotaSOFT Insertion System IM-03.

Generated automatically from registry data and not verified by a human reviewer.