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-1461-2026

Original 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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