FDA Registration
Active
🇺🇸 United States
BODY ARMOR SPORT
Reg #: 1122845
·
FEI: 1000123428
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- DARCO INTERNATIONAL, INC.
- Registration Number
- 1122845
- FEI Number
- 1000123428
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 810 MEMORIAL BLVD.
- City
- HUNTINGTON
- State
- WV
- ZIP
- 25701
- Country
- US
Owner / Operator
- Firm Name
- DARCO INTERNATIONAL, INC.
- Operator Number
- 9001626
- Address
- 810 MEMORIAL BLVD., --
- City
- Huntington
- State
- WV
- Postal Code
- 25701
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2006-07-17 |
Proprietary Names
BODY ARMOR SPORT
EXTERNAL BRACE
DARCOGEL ANKLE BRACE
DARCO ANKLE BRACE
BODY ARMOR STIRRUP
BODY ARMOR VARIO
WEB ANKLE BRACE
ANKLE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device