SACS PRO

The SACS PRO is a lightweight, portable, battery-powered compression device that wraps around the lower leg and delivers sequential compression through three electro-active polymer straps to stimulate blood flow. It is intended for over-the-counter use to temporarily relieve minor muscle aches and pains and temporarily increase circulation in the legs, for use in clinical, home, athlete training, and hospital settings.

The SACS PRO uses three compression straps controlled by a microprocessor to deliver sustained and intermittent compression up to 40 mmHg with a 30-second cycle duration. It is lightweight (<1 kg), battery-powered with rechargeable AA NiMH batteries, features LED/buzzer indicators, operates via a one-touch control box with user interface, and is supplied non-sterile with Velcro closure. Unlike the primary predicate (Normatec Go), which uses air inflation and offers variable compression modes up to 220 mmHg, the SACS PRO matches the secondary predicate's mechanical design and specifications exactly.

ANSI AAMI IEC 60601-1-2:2014 (EMC), ANSI AAMI ES60601-1:2005/(R)2012 (electrical safety), ANSI AAMI IEC 62304:2006/A1:2016 (software validation), and FDA's Content of Premarket Submissions for Device Software Functions guidance.

The SACS PRO is substantially equivalent because it shares identical intended use and OTC indications for use as the primary predicate (Normatec Go) — temporary relief of minor muscle aches and increased circulation. Though the SACS PRO uses different compression technology (electro-active polymer straps versus air inflation), it achieves the same functional outcome of microprocessor-controlled sequential compression stimulating blood flow in the lower limbs. The device is physically and functionally identical to the secondary predicate (SACS K232300), differing only in regulatory classification (OTC versus prescription), and all performance testing conducted on the identical secondary predicate device demonstrates it meets requirements for the intended use.