FDA Registration
Active
🇺🇸 United States
Hugh Steeper Ltd DBA SteeperUSA
Reg #: 3017697481
·
FEI: 3017697481
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- Hugh Steeper Ltd DBA SteeperUSA
- Registration Number
- 3017697481
- FEI Number
- 3017697481
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 77 Main St Ste 7
- City
- Hopkinton
- State
- MA
- ZIP
- 01748
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Elbow, External Limb Component, Mechanical | IRD | Class 1 | Physical Medicine | No | 2021-06-09 |
| 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 |
| Unit, Wrist, External Limb Component, Mechanical | ISZ | Class 1 | Physical Medicine | No | 1987-03-17 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 1987-03-17 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 1987-03-17 |
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
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Remanufacture Medical Device