Device product
PIE Trolley System Model: 2005
Z-1461-2026
Product summary
- Firm
- Edermy LLC
- Event
- Event 98303
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-1461-2026
Official wording
Reason: Lack of 510K clearance
Code information: All Lots
Distribution pattern: 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.
Derived failure modes
-
Unknown
Lack of 510K clearance