Chrysalis Intelligence · Sponsors · Iotamotion, Inc.

Iotamotion, Inc.

Iowa City, IA, US · 2 510(k) clearances · 1 recalls

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Total clearances
2
2021-10-01 → 2026-01-09
Last 12 months
1
Product codes
1
Most recent
2026-01-09
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QQH Powered Insertion System For A Cochlear Implant Electrode Array Class II Ear, Nose, Throat 2 2026-01-09
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
0
Most recent
2024-09-12
DateSeverityStatusRecall # ProductCodeReason
2024-09-12 Class III Completed Z-0288-2025 iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochle… — Incorrect GTIN number.
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2026-01-09 K252339 iotaSOFT® Insertion System QQH Class II Ear, Nose, Throat
2021-10-01 DEN190055 iotaSOFT Insertion System - Drive Unit, Controller and Accessories QQH Class II Ear, Nose, Throat
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence