Certifications

CE Certification – ZPower Rechargeable System for Hearing Aids

ISO 13485:2003 – Design and Manufacture of ZPower Rechargeable System for Hearing Aids

ISO 13485:2016 – Design, Manufacturing, Marketing and Distribution of ZPower Rechargeable System and Sub-Systems for Hearing Aids

ISO 9001:2008 – ZPower, LLC

FDA – Registered Medical Device Establishment

In October, 2015, ZPower’s Camarillo, California facility achieved FDA registration as a Medical Device Establishment for the manufacturing of medical device accessories. According to Title 21 of the Code of Federal Regulations, establishments that manufacture medical devices for human use must register with the FDA.