FDA Registration
Active
🇨🇳 China
Quantum Foot Shell
Reg #: 3013014172
·
FEI: 3013014172
·
Expires 2025
Products
1
Proprietary Names
28
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Fujian Guozi Rehabilitation Medical co., ltd
- Registration Number
- 3013014172
- FEI Number
- 3013014172
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.50 Gaofeng SouthLane, Westgate
- City
- Fuzhou Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Fujian Guozi Rehabilitation Medical co.,ltd
- Operator Number
- 10052023
- Address
- No.50 Gaofeng SouthLane Westgate
- City
- Fuzhou
- State
- Fujian
- Postal Code
- 350001
- Country
- CN
- Correspondent
- Lucinda Chen
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2016-06-01 |
Proprietary Names
Quantum Foot Shell
1M Multiflex Foot
2SR420 Pneumatic Knee Joint
1MA Pyramid Multiflex Ankle
1101 single axis foot
1102 SACH foot
2N02 Foot Adapter for EZ Step foot
Upper limb Adapters
1FS Carbon Fiber Foot
1E20 Keel For EZ Step Foot
Socket Accessory
1FC40/1FC45/1FC60 Carbon fiber foot
Lower limb metal adapters
1FS Bosun Foot (Dynamic carbon foot)
Fabrication tools
Knee Joint
1P01 Pirogof foot
Silicone Gloves
Hand
RGO and Orthotic Joint
Prosthetics Accessory
Prosthetics Multicolor Pad
Hip joint
1FO Ossur footshell
Sanding Toold for Roubers
Children Adapters
1FC freedom footshell
Prosthetics cosmesis
Establishment Types
Manufacture Medical Device