FDA-Device2019-05-22Class II
MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Compass Health Brands (Corporate Office)
Hazard
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Sold states
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
Manufactured in
6753 Engle Rd, Middleburg Heights, OH, United States
Products
MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1345-2019Don't want to check this manually?
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