FDA device listing
Tweak Enhance OTC,Tweak Focus + T, Plaid, Tune Amp Focus + T
FDA device listing 1256739304 · EAR TECHNOLOGY CORPORATION
Key facts
| Proprietary names | Tweak Enhance OTC,Tweak Focus + T, Plaid, Tune Amp Focus + T |
|---|---|
| Owner/operator | EAR TECHNOLOGY CORPORATION |
| Owner/operator number | 9007312 |
| Product codes | QUF |
| Device names | QUF - Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.3300 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | EAR TECHNOLOGY CORPORATION |
| Establishment registrations | 1056339 |
| FEI numbers | 1000140463 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database