Panthera AB
SwedenFDA applicant, unverified
- Devices
- 1
What Panthera AB makes
Panthera AB manufactures infant and toddler swing devices, including models such as the Bambino 3, S3, S3 Swing, U3, U3 Light, and X. These products are designed for use in home and clinical settings to provide gentle motion support for young children.
The company’s portfolio is classified under FDA Class I medical devices and is subject to 510(k) clearance in the United States. The devices are listed in the FDA’s regulatory database under this classification.
Catalogue
Bambino 3, S3 and S3 Swing, U3 and U3 Light, X Ref K220698
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Panthera AB have in the registry?
The registry currently lists 1 device for Panthera AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Panthera AB's devices?
Among its 1 most recently registered device, Panthera AB has devices listed in FDA 510(k) (1 device).
What risk classes do Panthera AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Panthera AB's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Panthera AB in the registry?
The most recently registered devices listed for Panthera AB include Bambino 3, S3 and S3 Swing, U3 and U3 Light, X.