Ion Genius, Inc.

Medical device manufacturer in Honolulu, HI.

2510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K132179ArasysNGX · Traditional 04/28/2014SE
K123158Ion Magnum GeniusNGX · Traditional 06/21/2013SE

Recalls

RecallProductInitiated
Z-1141-2012 Arasys Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… 01/06/2012Terminated
Z-1140-2012 iPico Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… 01/06/2012Terminated
Z-1139-2012 IELLIOS Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… 01/06/2012Terminated
Z-1138-2012 Ion Magnum Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… 01/06/2012Terminated
Z-1137-2012 Perfector Product Usage: Muscle stimulationWires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations.… 01/06/2012Terminated