Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010605477

FEI Number

3010605477

Entity Name

SMIRTHWAITE LTD

City/State/Country

Newton Abbot Devon, GB

Establishment Address

16 Wentworth Road, Heathfield, Newton Abbot Devon TQ212 6TL, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Smirthwaite Ltd (Owner Number: 10045465)

Owner / Operator Contact Address

16 Wentworth Road, Heathfield, Newton Abbot, GB-DEV TQ212 6TL, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Snooooooze Little Dots System Bath Corner Chair Buddy Body Roller Smirthwaite USA LLC Round Therapy Stool Therapy Bench Combi Bath Chair Adjustable Height Wheely Stool Star Snooooooze Sleep System Hip Spica Hardrock Felix Brookfield Heathfield Zoomi+ Zoomi Corner Chair Asiento Juni Suni Smirthwaite USA LLC Hi Riser Shower Stretcher Mobi Heavy Duty Changer Mobi Shower Trolley Mobi Changer Easi-Lift Changing Bench Easi-Lift Shower Stretcher Essential Changing Table Shower Stretcher Fixed Hi-Riser Changing Bench

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2013-11-20
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2013-11-20
INW	Table, Mechanical	Physical Medicine	Class 1	890.3750	2013-11-20

Official Correspondent

Claire Litton

US Agent Details

Chris Doran Business: Smirthwaite USA LLC Email: chris.doran@smirthwaite.com Phone: (212) 5412455

Related Public Records

Same Entity

Smirthwaite Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010605477. Last updated year: 2026. Please use registration number 3010605477 when referencing this establishment in official correspondence.