Data / Medical devices / United Kingdom / Hugh Steeper Ltd
Hugh Steeper Ltd: FDA-registered device maker in Leeds, England, United Kingdom, 1 510(k) clearance
Hugh Steeper Ltd is registered with the FDA (registration 9612243) in Leeds, England, United Kingdom. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 29, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612243
- FEI number
- 3003702031
- Address
- Unit 3, Stourton Link Intermezzo Drive, Leeds, England, United Kingdom, LS10 1DF
- Owner or operator
- Hugh Steeper Ltd (8021993)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer
- First device listed
- March 17, 1987
- Registered through
- 2026
- Brand names listed
- Auto Elbow (Mk14), Espire Basic, Classic, Classic +, ELEC 60, Elegance glove, Espire Elbow, Prosthesis, Skinergy, Spring op hand, Cable op hand, bebionic and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Limb | IPM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Hand, External Limb Component, Mechanical | IRA | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Hand, External Limb Component, Powered | IQZ | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Joint, Elbow, External Limb Component, Mechanical | IRD | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Joint, Elbow, External Limb Component, Powered | IRE | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | 1 | Complaint file establishment, Manufacturer, Remanufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 29, 2018 | K182757 | Espire Elbow Pro, Espire Elbow Hybrid | GXY | Substantially Equivalent | College Park Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Hand, External Limb Component, Powered
- All makers of Electrode, Cutaneous
- All makers of Joint, Elbow, External Limb Component, Powered
- All makers of Joint, Elbow, External Limb Component, Mechanical
- All makers of Cover, Limb
- All makers of Unit, Wrist, External Limb Component, Mechanical
Updated November 29, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.