SONA PILLOW

Description of Event or Problem

PURCHASED SONA PILLOW -FDA #K040161-AND USED ACCORDING TO INSTRUCTIONS. RESULTED IN DISABLING NECK PAIN. WANTED TO RETURN THE "MEDICAL DEVICE" AND WAS TOLD BY COMPANY -SLEEP DEVICES INC.- IT WAS NOT RETURNABLE DUE TO FDA REGULATIONS.** I RESEARCHED THE FDA APPROVAL OF THIS "DEVICE" AND FOUND IT WAS APPROVED "UNDER 872.557, INTRAORAL DEVICES FOR SNORING AND OBSTRUCTIVE SLEEP APNEA." PLEASE NOTE, THIS IS NOT AN INTRAORAL DEVICE - IT IS A PILLOW THAT YOU PLACE YOUR HEAD ON DURING SLEEP. **QUOTE FROM WWW.SONAPILLOW.COM "RETURNS/POLICIES FEDERAL LAWS ON RETURNING BEDDING PRODUCTS ARE SIMILAR TO THE LAWS GOVERNING THE RETURN OF UNDERWEAR. FURTHERMORE, THE SONA PILLOW IS A PERSONAL MEDICAL DEVICE. USED MEDICAL EQUIPMENT CANNOT BE RETURNED, UNLESS THERE IS A MFG DEFECT IN THE PRODUCT."