Logo, Axiobionics, Therapy Garments in Ann Arbor, MI

(800) 552-3539
 (734) 327-2946
6111 Jackson Road
Ann Arbor, MI 48103
 
       an innovative approach to rehabilitation  

Axiobionics Logo, Wearable Therapy

       

 

 

Lady With a Horse, Wearable Therapy      

                 Quality

Quality Policy:
Axiobionics designs, manufactures and fits Wearable Therapy Surface Electrical Stimulation Systems for patients with chronic disability. We are committed to the highest level of innovation, research, manufacturing and quality patient care possible. To achieve this for our patients we implement and maintain FDA good manufacturing practices in accordance with FDA QSR 21 CFR Part 820: Medical Devices- Quality Management Systems- Requirements for Regulatory Purposes.

The Axiobionics Wearable Therapy Surface Electrical Stimulation System is a class II medical device cleared for marketing in the US by the FDA.

Surface Electrical Stimulation System refers to 21 CFR Sec. 882.1320 Cutaneous electrode: “(a) Identification. A cutaneous electrode is an electrode that is applied directly to a patient’s skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.”

CAUTION: Federal law restricts the device to sale by or on the order of a physician or a practitioner trained in its use.
                    

© 2014 Axiobionics, LLC (800) 552-3539

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