Data / Medical devices / United States / Spoonwood Ecommerce LLC
Spoonwood Ecommerce LLC: FDA-registered device maker in Dover, DE, United States, 1 510(k) clearance
Spoonwood Ecommerce LLC is registered with the FDA (registration 3041658266) in Dover, DE, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3041658266
- Address
- 8 The Green STE 8, Dover, DE, United States, 19901
- Owner or operator
- Spoonwood Ecommerce LLC (10094117)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- November 15, 2025
- Registered through
- 2026
- Brand names listed
- The Hearing Co.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2023 | K221052 | Self-Fitting hearing aids | QUH | Substantially Equivalent | Huizhou Jinghao Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Hearing Aid, Air-Conduction, Over The Counter
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
Updated September 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.