Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017697481

FEI Number

3017697481

Entity Name

Hugh Steeper Ltd DBA SteeperUSA

City/State/Country

Hopkinton, MA, US

Establishment Address

77 Main St Ste 7, Hopkinton, MA 01748, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device

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

Auto Elbow (Mk14), Espire Basic, Classic, Classic + Espire Elbow bebionic glove Elegance glove Skinergy 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
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2021-06-09
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
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	1987-03-17
IQZ	Hand, External Limb Component, Powered	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

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9612243	HUGH STEEPER LTD	LEEDS, ENGLAND, GB

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

Similar Registrations

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9710641	SEI Medical S.A. de C.V.	Juarez Chihuahua, MX
1824252	BECKER ORTHOPEDIC APPLIANCE CO.	TROY, MI, US
3013856565	HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD	Hengshui Hebei, CN
9616933	I-MING SANITARY MATERIALS CO., LTD.	Changhua, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017697481. Last updated year: 2026. Please use registration number 3017697481 when referencing this establishment in official correspondence.