FDA device listing
Behind The Ear Hearing Aid/TE-002M, TE-003M, TE-004M, TE-005M, TE-006M, TE-007M, TE-008M, TE-009M, TE-112M,Behind The…
FDA device listing 1298126774 · Zhongshan Tianle Hearing Technology Co.,Ltd
Key facts
| Proprietary names | Behind The Ear Hearing Aid/TE-002M, TE-003M, TE-004M, TE-005M, TE-006M, TE-007M, TE-008M, TE-009M, TE-112M,Behind The Ear Hearing Aid/TE-113M, TE-115M, TE-116M, TE-119M, TE-200M, TE-211M, TE-212M, TE-213M,Behind The Ear Hearing Aid/TL-007AM, TL-008AM, TL-009AM, TL-115M, TL-112M, TL-113M, TL-116M, TL-117M, TL-118M,Behind The Ear Hearing Aid/TL-119M, TL-611M, TL-612M, TL-613M, TL-615M, TL-616M… |
|---|---|
| Owner/operator | Zhongshan Tianle Hearing Technology Co.,Ltd |
| Owner/operator number | 10092762 |
| Product codes | OSM |
| Device names | OSM - Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | ZHONGSHAN TIANLE HEARING TECHNOLOGY CO.,LTD |
| Establishment registrations | 3037001880 |
| FEI numbers | 3037001880 |
| Establishment operations | Manufacturer |
| 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