PPOD Orthotics Inc.

PPOD Orthotics Inc. specializes in cranial orthoses, which are devices designed to help manage cranial deformities in infants. Their most common product category is cranial orthoses, with an example device being the P-POD.

PPOD Orthotics Inc. is based in the United States. This location is relevant for regulatory compliance and distribution, as it aligns with the FDA’s jurisdiction over medical devices in the country.

PPOD Orthotics Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices for regulatory, safety, and market surveillance purposes.

PPOD Orthotics Inc.’s devices fall under FDA Class II classification. This classification typically indicates moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness.