DRX9000C-SL Cervical Spinal Decompression System

The DRX9000C-SL Cervical Spinal Decompression System is a powered traction device designed to apply controlled decompressive forces to the cervical spine to relieve neck pain. It is intended for prescription use in professional healthcare facilities and can treat conditions including herniated discs, protruding discs, degenerative disc disease, and posterior facet syndrome.

The subject device uses electromechanical traction with software-controlled servo amplifier and servo motor, applying variable traction forces between 0–50 lbs continuously over 30–45 minutes. Key differences from the predicate (DRX5000): the subject device is cervical-only (predicate treats cervical and lumbar), has lower maximum traction force (50 lbs vs. 200 lbs), and incorporates modern electrical safety and EMC standards (IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-2:2014 + A1:2020).

IEC 60601-1:2005 + A1:2012 + A2:2020 (electrical safety); IEC 60601-1-2:2014 + A1:2020 (electromagnetic compatibility); IEC 60601-1-6:2010 + A1:2013 + A2:2020 (usability); ISO 14971:2019 (risk management); ISO 10993-1:2018 (biocompatibility); IEC 62304:2006 + A1:2015 (software lifecycle).

Both devices use the same electromechanical traction mechanism to decompress intervertebral discs and treat similar cervical spine conditions via distraction forces. Although the subject device is limited to cervical treatment and has a lower maximum force (50 lbs vs. 200 lbs), these are narrower intended uses and operational parameters—not fundamental design changes. The subject device meets modern consensus standards for electrical safety, EMC, and usability that the predicate information did not publicly disclose, demonstrating equivalent or superior technical performance without raising new safety or effectiveness concerns.