Pinook USA
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Pinook Stimulator Ref K132563
Regimes: 510(k) Registry: 510(k)
FDA recalls
2013
- 23 May 2013 Z-0176-2014 Class II Terminated Failure to submit a premarket submission and gain approval of a medical device.
Full distribution text
- 23 May 2013 Z-0177-2014 Class II Terminated Failure to submit a premarket submission and gain approval of a medical device.
Full distribution text
- 23 May 2013 Z-0176-2014 Class II Terminated Failure to submit a premarket submission and gain approval of a medical device.
Frequently asked questions
How many devices does Pinook USA have in the registry?
The registry currently lists 1 device for Pinook USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pinook USA's devices?
Among its 1 most recently registered device, Pinook USA has devices listed in FDA 510(k) (1 device).
What risk classes do Pinook USA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Pinook USA's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pinook USA?
FDA recall records list 2 recalls initiated by Pinook USA, the most recent initiated on 23 May 2013. 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 Pinook USA in the registry?
The most recently registered devices listed for Pinook USA include PINOOK STIMULATOR.