MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

Reason: Product design change did not receive proper premarket clearance and lacks a 510 (k)

Code information: All Serial Numbers/Lots

Distribution pattern: Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada