Home / Companies / Iotamotion Inc

Iotamotion Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0288-2025Class IIIiotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon inSeptember 12, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K252339iotaSOFT® Insertion SystemJanuary 9, 2026
DEN190055iotaSOFT Insertion System - Drive Unit, Controller and AccessoriesOctober 1, 2021