6 results
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56ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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James Leckey Design Ltd
FDA registration
James Leckey Design Ltd·2 products·🇬🇧 United Kingdom
Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193
FDA Recall
Terminated
·Patterson Medical Holdings, Inc.·Product code INN·April 17, 2009
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
FDA Enforcement
Class II
·Ongoing·James Leckey Design Ltd·April 15, 2020
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
FDA Enforcement
Class II
·Ongoing·James Leckey Design Ltd·June 2, 2021
Firefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The Splashy Bath-Seat is a Portable bath seat for children aged 1-8, The GoTo Seat is a light-weight, portable, postural support seat for kids, aged between 1 and 8 with disabilities.
FDA Recall
Open, Classified
·James Leckey Design Ltd 19C Ballinderry Road Lisburn United Kingdom·Product code ILS·February 18, 2020
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
FDA Recall
Open, Classified
·James Leckey Design Ltd 19C Ballinderry Road Lisburn United Kingdom·Product code ITJ·March 1, 2021