FDA Registration
Active
🇻🇳 Vietnam
V-10220128-628
Reg #: 3007076137
·
FEI: 3007076137
·
Expires 2025
Products
1
Proprietary Names
61
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Foundation Wellness International Co., LTD (FWIL)
- Registration Number
- 3007076137
- FEI Number
- 3007076137
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot C-8C-CN My Phouc Industrial Park 3, Ben Cat District
- City
- Binh Duong
- Country
- VN
Owner / Operator
- Firm Name
- REMINGTON PRODUCTS COMPANY LLC
- Operator Number
- 1832148
- Address
- 961 Seville Rd
- City
- Wadsworth
- State
- OH
- Postal Code
- 44281
- Country
- US
- Correspondent
- Kenneth L Block
US Agent
- Business Name
- Ken Block Consulting
- Contact Name
- Kenneth Block
- Address
- 3400 N Central Expy Ste 110265
- City
- Richardson
- State
- TX
- ZIP
- 75080
- Country
- US
- [email protected]
- Phone
- 972 4809554
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2010-04-28 |
Proprietary Names
V-10220128-628
V-VN1703-00
000799(001-008)00
V-1758
V-102401-06
V-1750
V-VN1704-00
V-113711-13-15
V-1754BL-(06-07)
V-ORT1900LD/RD
00179800100
V-CS2240XS-2XL
ORT19300L-R
V-1749-00
V-ORT16100(XS-2XL)
V-1755BL-(08-17)
V-1742
V-SEMI19810S-L
R1754BL-(08-17)
V-ORT19400D
V-112721-22-23-25
V-P081448(33A-44A)
V-112711-12-13-15
V-1753-(01-02)
V-ORT18110
V-113721-23-25
VN1700-UNIR-L
V-ORT19400KD
V-1754BL-(08-17)
V-ORT19100
V-1755BL-(01-02)
V-ORT19100D
V-182520
V-1757
V-112731-46
V-1754BL-(01-02)
V-ORT18210D
V-ORT19900
001769(002-003)00
V-ORT18210
1749-00
V-ORT19400
008600(529-530)00
100480-83 (501012-826117-118) (501012-826217-218)
00178500100
008601887(02-03)
V-CS2239XS-2XL
V-ORT19210S-XL
001759(001-008)00
001799(001-010)
P08144240-41
003447(303-306)(403-406)00
V-113731-46
V-VN111731-46
V-102201-06
V-VN1702-00
MW-144-100(29-30)
ORT19310L-R
V-SEMI1702-00
V-ORT19810S-L
V-111721-22-23-25
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device