FDA Registration
Active
🇬🇧 United Kingdom
OPEN BIONICS
Reg #: 3012881757
·
FEI: 3012881757
·
Expires 2026
Products
4
Proprietary Names
10
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OPEN BIONICS
- Registration Number
- 3012881757
- FEI Number
- 3012881757
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Programme, Tower Lane
- City
- Bristol Bristol, City of
- Country
- GB
Owner / Operator
- Firm Name
- Open Bionics
- Operator Number
- 10055870
- Address
- Programme, Tower Lane
- City
- Bristol
- State
- GB-NOTA
- Postal Code
- BS1 2NB
- Country
- GB
US Agent
- Business Name
- Emergo Global Consulting LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hook, External Limb Component, Mechanical | IQX | Class 1 | Physical Medicine | No | 2025-02-05 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2017-10-13 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2024-04-05 |
| Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | KFT | Class 1 | Physical Medicine | No | 2023-12-07 |
Proprietary Names
Gripster (weightlifting)
Builder
Rider (cycling)
Swinger (gymnastics)
Prana (Yoga, Pushups)
Drummer
Hero AIR
Hero RGD
Hero PRO
Hero Flex
Establishment Types
Manufacture Medical Device