James Leckey Design Ltd

FDA Regulatory Profile

James Leckey Design Ltd appears in FDA public data with 2 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1687-2021, Class II) was initiated on March 1, 2021. Its most recent 510(k) clearance was granted on December 22, 1994.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1687-2021Class IIMyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walMarch 1, 2021
Z-1683-2020Class IIFirefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-SFebruary 18, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K944308JAMES LECKEY FREE STANDERDecember 22, 1994
K944307JAMES LECKEY PRONE STANDERDecember 22, 1994