Orthotic & Prosthetic Lab, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Orthotic & Prosthetic Lab, Inc. makes
The company designs and manufactures cranial molding helmets for orthotic and prosthetic applications, including single-piece and bivalve models used in pediatric cranial remolding therapy.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates within the United States.
Catalogue
O&P Cranical Molding Helmet Ref K021221
Regimes: 510(k) Registry: 510(k)O&P Bivalve Cranial Molding Helmet Ref K063395
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthotic & Prosthetic Lab, Inc. have in the registry?
The registry currently lists 2 devices for Orthotic & Prosthetic Lab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthotic & Prosthetic Lab, Inc.'s devices?
Among its 2 most recently registered devices, Orthotic & Prosthetic Lab, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Orthotic & Prosthetic Lab, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orthotic & Prosthetic Lab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthotic & Prosthetic Lab, Inc. in the registry?
The most recently registered devices listed for Orthotic & Prosthetic Lab, Inc. include O&P CRANICAL MOLDING HELMET and O&P BIVALVE CRANIAL MOLDING HELMET.