Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612243

FEI Number

3003702031

Entity Name

HUGH STEEPER LTD

City/State/Country

LEEDS, ENGLAND, GB

Establishment Address

Unit 3, Stourton Link, Intermezzo Drive, LEEDS, ENGLAND LS10 1DF, GB

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Hugh Steeper Ltd (Owner Number: 8021993)

Owner / Operator Contact Address

Unit 3, Stourton Link, Intermezzo Drive, Stourton, LEEDS, ENGLAND, GB-NOTA LS10 1DF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Espire Elbow bebionic glove Elegance glove Skinergy Auto Elbow (Mk14), Espire Basic, Classic, Classic + ELEC 60 bebionic Prosthesis Spring op hand, Cable op hand

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-11-26
IRE	Joint, Elbow, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	2020-11-26
IPM	Cover, Limb	Physical Medicine	Class 1	890.3025	2017-04-24
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2021-06-09
IQZ	Hand, External Limb Component, Powered	Physical Medicine	Class 1	890.3420	1987-03-17
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1987-03-17
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1987-03-17

Official Correspondent

Tony Coulson

US Agent Details

Kristine Yeagley Business: Steeper USA Email: Kristine.Yeagley@SteeperUSA.com Phone: (210) 4814126

Related Public Records

Same Entity

Hugh Steeper Ltd

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008259931	Steeper USA	San Antonio, TX, US
3017697481	Hugh Steeper Ltd DBA SteeperUSA	Hopkinton, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612243. Last updated year: 2026. Please use registration number 9612243 when referencing this establishment in official correspondence.