James Leckey Design Ltd

Lisburn Lisburn and Castlereagh, GB

James Leckey Design Ltd appears in FDA device records in Lisburn Lisburn and Castlereagh, GB. FDA records list 2 510(k) clearances, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for James Leckey Design Ltd in 1994.

Clearances by year, as a table

510(k) clearance decisions for James Leckey Design Ltd, by decision year
Year	Clearances
1994	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K944308	JAMES LECKEY FREE STANDER	INW	Substantially Equivalent	1994-12-22
K944307	JAMES LECKEY PRONE STANDER	INW	Substantially Equivalent	1994-12-22

Registered establishments

FDA registered establishments for James Leckey Design Ltd, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
9681189	3010712784	James Leckey Design Ltd	19 Ballinderry Road, Lisburn Lisburn and Castlereagh BT28 2SA GB	2026	ILT ION

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1687-2021	MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.	Due to a failure of the welds, the casters detached from the rear legs of the walker.	Class II	2021-03-01	Open, Classified
Z-1683-2020	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.	The firm received reports of a number of broken latches on the floorsitter.	Class II	2020-02-18	Open, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets James Leckey Design Ltd edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain