Precision Prosthetics & Orthotics, Inc.
Country not established
- Devices
- 1
What Precision Prosthetics & Orthotics, Inc. makes
Precision Prosthetics & Orthotics, Inc. manufactures orthotic devices, including custom helmet molding systems designed for medical and rehabilitative applications. These products are tailored for clinical use in fitting protective headgear for patients requiring orthotic support or cranial reshaping.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Orthosis Helmet Molding Ref K013700
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Precision Prosthetics & Orthotics, Inc. have in the registry?
The registry currently lists 1 device for Precision Prosthetics & Orthotics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Precision Prosthetics & Orthotics, Inc.'s devices?
Among its 1 most recently registered device, Precision Prosthetics & Orthotics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Precision Prosthetics & Orthotics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Precision Prosthetics & Orthotics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Precision Prosthetics & Orthotics, Inc. in the registry?
The most recently registered devices listed for Precision Prosthetics & Orthotics, Inc. include ORTHOSIS HELMET MOLDING.