Ion Genius, Inc.
Honolulu, HI, US
Ion Genius, Inc. appears in FDA device records in Honolulu, HI. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Ion Genius, Inc. between 2013 and 2014. The busiest year on record is 2013, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1141-2012 | Arasys Product Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA | Terminated | ||
| Z-1140-2012 | iPico Product Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA | Terminated | ||
| Z-1139-2012 | IELLIOS Product Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA | Terminated | ||
| Z-1138-2012 | Ion Magnum Product Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA | Terminated | ||
| Z-1137-2012 | Perfector Product Usage: Muscle stimulation | Wires do not meet performance standards under 21 CFR 898 and have unprotected electrode configurations. Additionally, devices were sold/distributed without 510(k) or PMA | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain