# Iotamotion, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/iotamotion-inc>
- Country: United States (FDA applicant, unverified)
- Role: Manufacturer
- Registrations: FDA
- FDA FEI: 3030411493
- DUNS: 080053045

## Figures

- Devices: 8
- FDA recalls (matched to the firm by name): 1

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 6, FDA 510(k) 2
- Device classes: FDA Class II 8

## Devices

The first 8 of 8, in the order of the canonical page, which lists them all.

- [iotaSOFT Insertion System IM-05](https://devicerts.com/devices/iotasoft-insertion-system-im-05) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System IM-00](https://devicerts.com/devices/iotasoft-insertion-system-im-00) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System IM-04](https://devicerts.com/devices/iotasoft-insertion-system-im-04) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System IM-03](https://devicerts.com/devices/iotasoft-insertion-system-im-03) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System IM-02](https://devicerts.com/devices/iotasoft-insertion-system-im-02) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System IM-01](https://devicerts.com/devices/iotasoft-insertion-system-im-01) · Class II · GUDID · status: Active
- [iotaSOFT Insertion System - Drive Unit, Controller and Accessories](https://devicerts.com/devices/iotasoft-insertion-system-drive-unit-controller-and-accessor-qqh) · ref DEN190055 · Class II · De Novo · status: Active · decision 2021-10-01
- [iotaSOFT® Insertion System](https://devicerts.com/devices/iotasoft-r-insertion-system-qqh) · ref K252339 · Class II · 510(k) · status: Active · decision 2026-01-09

## FDA recalls (matched by name, newest first)

- Z-0288-2025 · Class III · Completed · initiated 2024-09-12 · product code QQH: Incorrect GTIN number.

## Source and citation

- Cite as: Iotamotion, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/iotamotion-inc (data as of 2026-11-15).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/iotamotion-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/iotamotion-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.