FDA Registration
Active
🇺🇸 United States
THE SOULE CO
Reg #: 1059079
·
FEI: 1000525333
·
Expires 2026
Products
6
Proprietary Names
6
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- THE SOULE CO
- Registration Number
- 1059079
- FEI Number
- 1000525333
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 26543 Wild Fern Cir.
- City
- LUTZ
- State
- FL
- ZIP
- 33559
- Country
- US
Owner / Operator
- Firm Name
- THE SOULE CO., INC.
- Operator Number
- 9020536
- Address
- 4322 PET LN., --
- City
- Lutz
- State
- FL
- Postal Code
- 33559
- Country
- US
- Correspondent
- Lindsey - Osborne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2008-05-15 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2008-06-03 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2008-05-15 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2008-05-15 |
| Board, Arm (With Cover), Non-Sterile | NOD | Class 1 | General, Plastic Surgery | No | 2008-05-15 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2008-05-15 |
Proprietary Names
BEDDING, DISPOSABLE, MEDICAL
ORTHOSIS, LIMB BRACE
SUPPORT, PATIENT POSITION
SPLINT, HAND, AND COMPONENTS
Board, arm (with cover), non-sterile
seat Cushion (non flotation)
Establishment Types
Manufacture Medical Device