FDA-Device2026-03-04Class II
PIE PAK Models: P2HC-A, P2HC-S, P2HC
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
11202 units
Manufactured in
115 Enterprise Dr Ste A, N/A, Pendergrass, GA, United States
Products
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2026Original summary
PIE PAK Models: P2HC-A, P2HC-S, P2HC Lack of 510K clearance All Lots UDI: 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: 11202 units
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