Every UNIONCARE product is manufactured in an ISO 13485 certified, FDA-registered facility. We maintain a US Agent on file for FDA communication, and our walkers and rollators are 510(k) exempt.
Medical device quality management system certification for the manufacturing facility.
Manufacturing facility registered with the US Food and Drug Administration.
A designated US Agent for FDA correspondence and import questions.
Walkers and rollators fall under 510(k) exempt device classifications.
Documented weight capacity ratings — up to 800 lb on bariatric models.
Certificates and device listings shared with serious wholesale buyers under NDA.