FDA Registration
Active
🇬🇧 United Kingdom
GyroGlove - Medium Right
Reg #: 3030089870
·
FEI: 3030089870
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GYROGEAR LIMITED
- Registration Number
- 3030089870
- FEI Number
- 3030089870
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 90A High Street
- City
- Berkhamsted Hertfordshire
- Country
- GB
Owner / Operator
- Firm Name
- GyroGear Limited
- Operator Number
- 10089356
- Address
- 90A High Street
- City
- Berkhamsted
- State
- Hertfordshire
- Postal Code
- HP4 2BL
- Country
- GB
- Correspondent
- John D Piontkowski
US Agent
- Business Name
- GyroGear LLC
- Contact Name
- Faii Ong
- Address
- 240 Elm Street, #0214
- City
- Somerville
- State
- MA
- ZIP
- 02144
- Country
- US
- [email protected]
- Phone
- 617 3363265
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical | KFT | Class 1 | Physical Medicine | No | 2023-11-30 |
Proprietary Names
GyroGlove - Medium Right
GyroGlove - Large Right
GyroGlove Right Extra Large
GyroGlove Left Extra Large
GyroGlove Right Small - Dual Battery and Dual Harness
GyroGlove Left Medium - Dual Battery and Dual Harness
GyroGlove Left Small - Dual Battery and Dual Harness
GyroGlove - Small Right
GyroGlove Right Medium - Dual Battery and Dual Harness
GyroGlove - Small Left
GyroGlove Right Large - Dual Battery and Dual Harness
GyroGlove - Medium Left
GyroGlove Right Extra Large - Dual Battery and Dual Harness
GyroGlove Left Large - Dual Battery and Dual Harness
GyroGlove Left Extra Large - Dual Battery and Dual Harness
GyroGlove - Large Left
Establishment Types
Manufacture Medical Device