Ion Genius, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 5
At a glance
Market reach
- United States
- FDA recalls
What Ion Genius, Inc. makes
Ion Genius, Inc. manufactures the ARASYS and ION MAGNUM GENIUS, which are medical devices designed for iontophoresis and transdermal iontophoresis therapies. These devices are intended for controlled delivery of medications or substances through the skin using electrical current.
The company’s portfolio is regulated under Class II medical devices in the US, with devices listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Arasys Ref K132179
Regimes: 510(k) Registry: 510(k)Ion Magnum Genius Ref K123158
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 5 recalls initiated by Ion Genius, Inc., initiated on 2012-01-06. By recorded status: 5 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 6 Jan 2012 Z-1137-2012 Not yet classified Terminated 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
- 6 Jan 2012 Z-1138-2012 Not yet classified Terminated 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
- 6 Jan 2012 Z-1139-2012 Not yet classified Terminated 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
- 6 Jan 2012 Z-1140-2012 Not yet classified Terminated 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
- 6 Jan 2012 Z-1141-2012 Not yet classified Terminated 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
Frequently asked questions
How many devices does Ion Genius, Inc. have in the registry?
The registry currently lists 2 devices for Ion Genius, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ion Genius, Inc.'s devices?
Among its 2 most recently registered devices, Ion Genius, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ion Genius, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ion Genius, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ion Genius, Inc.?
FDA recall records list 5 recalls initiated by Ion Genius, Inc., the most recent initiated on 6 Jan 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Ion Genius, Inc. in the registry?
The most recently registered devices listed for Ion Genius, Inc. include ARASYS and ION MAGNUM GENIUS.