FDA-Device2026-03-04Class II
PIE Trolley System Model: 2005
Edermy LLC
Hazard
Lack of 510K clearance
Sold states
US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO.
Affected count
27 units
Manufactured in
115 Enterprise Dr Ste A, N/A, Pendergrass, GA, United States
Products
PIE Trolley System Model: 2005
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1461-2026Original summary
PIE Trolley System Model: 2005 Lack of 510K clearance All Lots Distribution: US Nationwide distribution in the states of OH, AZ, IL, PA, IN, CA, MO, MA, MN, VA, FL, NY, AL, SC, NC, TN, TX, CO. Affected quantity: 27 units
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