FDA Registration
Active
🇺🇸 United States
SPOONWOOD ECOMMERCE LLC
Reg #: 3041658266
·
FEI: 3041658266
·
Expires 2026
Products
3
Proprietary Names
1
Establishment Types
2
Classifications
3
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Registration Details
- Registration Name
- SPOONWOOD ECOMMERCE LLC
- Registration Number
- 3041658266
- FEI Number
- 3041658266
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8 The Green STE 8
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221052
Owner / Operator
- Firm Name
- Spoonwood Ecommerce LLC
- Operator Number
- 10094117
- Address
- 8 The Green STE 8
- City
- Dover
- State
- DE
- Postal Code
- 19901
- Country
- US
- Correspondent
- Joshua Potyrala
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2025-12-06 |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | Class 2 | Ear, Nose, Throat | No | 2025-12-06 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2025-11-15 |
Proprietary Names
The Hearing Co.
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198