FDA Registration
Active
🇹🇼 Taiwan
Procare Bariatric G2
Reg #: 8043439
·
FEI: 3004411059
·
Expires 2025
Products
1
Proprietary Names
27
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Wellell Inc.
- Registration Number
- 8043439
- FEI Number
- 3004411059
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 9, MIN SHENG ST., TU-CHENG
- City
- NEW TAIPEI CITY
- Country
- TW
Owner / Operator
- Firm Name
- Wellell Inc.
- Operator Number
- 9001426
- Address
- No. 9, MIN SHENG ST., TU-CHENG,
- City
- NEW TAIPEI CITY
- State
- TW-TPE
- Postal Code
- 236044
- Country
- TW
- Correspondent
- Chieh - Yang
US Agent
- Business Name
- WELLELL AMERICA CORP.
- Contact Name
- Elsa Chu
- Address
- 927 Mariner Street, Brea, CA 92821, USA
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 714 6713818
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 1994-09-21 |
Proprietary Names
Procare Bariatric G2
Domus Auto G2
ACS Series Pump and Mattress
SERENE Series Pump and Mattress
Serene Bariatric
Sedens 500
Optima Auto
Optima Turn
Optima Prone
DOMUS Auto Pump and Mattress
Serene Elite
DOMUS 4 Pump and Mattress
DOMUS 1 Pump and Mattress
Serene Air
Procare Elite
DOMUS 2S Pump and Mattress
Procare Auto G3
DOMUS 3 Pump and Mattress
Domus ECO
Sedens 400
Procare Auto G2
Procare Auto Link G3
Domus Bariatric G2
Domus 2 G2
Domus 1 G2
PRO-CARE Series Pump and Mattress
Domus 4 G2 Pump
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device