Psi Health Solutions, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Psi Health Solutions, Inc. makes
Psi Health Solutions, Inc. manufactures PSI Bands, which are classified as Class II medical devices under FDA regulations.
These devices are listed in the FDA’s 510(k) registry and are regulated as Class II under the US medical device classification system. The company is based in the United States.
Catalogue
Psi Bands Ref K070766
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Psi Health Solutions, Inc., initiated on 2007-04-26. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 26 Apr 2007 Z-1821-2008 Unclassified (pre-2012) Terminated Product was marketed before its 510(k) application cleared.
Frequently asked questions
How many devices does Psi Health Solutions, Inc. have in the registry?
The registry currently lists 1 device for Psi Health Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Psi Health Solutions, Inc.'s devices?
Among its 1 most recently registered device, Psi Health Solutions, Inc. has devices listed in FDA 510(k) (1 device).
Are there FDA recall records for Psi Health Solutions, Inc.?
FDA recall records list 1 recall initiated by Psi Health Solutions, Inc., the most recent initiated on 26 Apr 2007. 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 Psi Health Solutions, Inc. in the registry?
The most recently registered devices listed for Psi Health Solutions, Inc. include PSI BANDS.