FDA Registration
Active
🇬🇧 United Kingdom
HUGH STEEPER LTD
Reg #: 9612243
·
FEI: 3003702031
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- HUGH STEEPER LTD
- Registration Number
- 9612243
- FEI Number
- 3003702031
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Unit 3, Stourton Link, Intermezzo Drive
- City
- LEEDS, ENGLAND
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K182757
Owner / Operator
- Firm Name
- Hugh Steeper Ltd
- Operator Number
- 8021993
- Address
- Unit 3, Stourton Link, Intermezzo Drive, Stourton
- City
- LEEDS, ENGLAND
- State
- GB-NOTA
- Postal Code
- LS10 1DF
- Country
- GB
- Correspondent
- Tony - Coulson
US Agent
- Business Name
- Steeper USA
- Contact Name
- Kristine Yeagley
- Address
- 8666 Huebner Rd, #112
- City
- San Antonio
- State
- TX
- ZIP
- 78240
- Country
- US
- [email protected]
- Phone
- 210 4814126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2020-11-26 |
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2020-11-26 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2017-04-24 |
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2021-06-09 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 1987-03-17 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 1987-03-17 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 1987-03-17 |
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
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device