FDA device listing
ELEHEAR FC04 Hearing aids; ELEHEAR FC04A Hearing aids;ELEHEAR FC04B Hearing aids;,ELEHEAR RIC 03,ELEHEAR RIC 03A,ELEHEAR…
FDA device listing 1240809416 · ELEHEAR Inc.
Key facts
| Proprietary names | ELEHEAR FC04 Hearing aids; ELEHEAR FC04A Hearing aids;ELEHEAR FC04B Hearing aids;,ELEHEAR RIC 03,ELEHEAR RIC 03A,ELEHEAR RIC 03B,ELEHEAR RIC 03C,ELEHEAR RIC 03L,ELEHEAR RIC 03M |
|---|---|
| Owner/operator | ELEHEAR Inc. |
| Owner/operator number | 10090276 |
| Product codes | QUG |
| Device names | QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | ELEHEAR INC. |
| Establishment registrations | 3030682076 |
| FEI numbers | 3030682076 |
| Establishment operations | Contract Manufacturer, Manufacturer, 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