Prapela, Inc.
United Statesfrom the FDA registration address FDA FEI 3048181753
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Prapela, Inc. makes
Prapela, Inc. manufactures hospital bassinet pads designed for use with SVS (Sleeping Vertical Support) bassinets, intended to provide a cushioned surface for infant care in clinical settings.
The company’s products are classified as Class II medical devices in the US and are listed under the FDA’s 510(k) pathway. Prapela, Inc. is based in the United States.
Catalogue
Prapela SVS hospital bassinet pad (model P01) Ref DEN240031
Regimes: De Novo Registry: De Novo
Company details
- FDA FEI number
- 3048181753
- Address
- 2 Monument Sq Ste 400, Portland, ME, 04101
Frequently asked questions
How many devices does Prapela, Inc. have in the registry?
The registry currently lists 1 device for Prapela, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prapela, Inc.'s devices?
Among its 1 most recently registered device, Prapela, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Prapela, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Prapela, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prapela, Inc. in the registry?
The most recently registered devices listed for Prapela, Inc. include Prapela SVS hospital bassinet pad (model P01).