Innovision A/S
Country not established
- Devices
- 4
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Innovision A/S makes
Innovision A/S manufactures cardiopulmonary exercise testing systems, including ergospirometry platforms with breath-by-breath analysis and non-invasive blood pressure (NIBP) monitoring. Their portfolio includes standalone and modular options, such as a cardiopulmonary exercise testing add-on and lung diffusion capacity (LCI) measurement capabilities for the INNOCOR system.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Innovision A/S is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Innocor Ref K051907
Regimes: 510(k) Registry: 510(k)Lci Option For Innocor Ref K102047
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Innovision A/S, initiated on 2016-05-13. 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.
2016
- 13 May 2016 Z-2769-2016 Class II Terminated The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer.
The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use.
The replacement is intended to prevent risk of electric shock.
Full distribution text
- 13 May 2016 Z-2769-2016 Class II Terminated The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer.
The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use.
The replacement is intended to prevent risk of electric shock.
Frequently asked questions
How many devices does Innovision A/S have in the registry?
The registry currently lists 4 devices for Innovision A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innovision A/S's devices?
Among its 4 most recently registered devices, Innovision A/S has devices listed in FDA 510(k) (4 devices).
What risk classes do Innovision A/S's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Innovision A/S's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Innovision A/S?
FDA recall records list 1 recall initiated by Innovision A/S, the most recent initiated on 13 May 2016. 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 Innovision A/S in the registry?
The most recently registered devices listed for Innovision A/S include INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500), CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR, INNOCOR and LCI OPTION FOR INNOCOR.