FDA Registration
Active
🇺🇸 United States
Foam Heel/Ankle/Foot protectors
Reg #: 3009402404
·
FEI: 3009402404
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Joerns Healthcare
- Registration Number
- 3009402404
- FEI Number
- 3009402404
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2100 Design Rd
- City
- Arlington
- State
- TX
- ZIP
- 76014
- Country
- US
Owner / Operator
- Firm Name
- JOERNS HEALTHCARE LLC
- Operator Number
- 9105099
- Address
- 2100 Design Road, --
- City
- Arlington
- State
- TX
- Postal Code
- 76014
- Country
- US
- Correspondent
- Mackenzie - Bay
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 1992-12-14 |
Proprietary Names
Foam Heel/Ankle/Foot protectors
Foam Arm/Elbow/Ulnar Protectors
Foam Wedges/Aligners
Foam Donuts
Foam Pillows
Foam Bolsters/Extenders, Siderails
Foam Headcradles
Foam Abduction Pillows
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility