Sequential Compression System (SCD600)

The SCD600 Sequential Compression System is a medical device that applies intermittent pneumatic compression to limbs to increase venous blood flow. It is designed to prevent deep vein thrombosis and pulmonary embolism and treat limb edema in professional healthcare facilities under medical staff supervision as part of a prescribed care plan.

The SCD600 uses manually preset venous refill time settings, whereas the predicate Kendall SCD 700 automatically measures and adjusts the time between compressions based on how long limbs take to refill with blood. Both are sequential compression systems with similar overall function, but the SCD600 requires staff to set the refill time before treatment begins.

ANSI AAMI ES60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2 Edition 4 (electromagnetic compatibility), IEC 60601-1-6 Edition 3.2 (usability), IEC 62366-1 Edition 1.1 (usability engineering), IEC 62304 Edition 1.1 (software life cycle), and ISO 14971 Third Edition (risk management). Transportation testing was also performed.

The SCD600 has the same indications for use and similar technological characteristics as the predicate device. Performance testing and compliance with FDA-recognized consensus standards demonstrate substantial equivalence. Biocompatibility was assessed using FDA-cleared materials with less than 24-hour skin contact, and functional testing confirmed the device meets specifications equivalent to the predicate.