Western Advanced Technology, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Western Advanced Technology, Inc. makes
Western Advanced Technology, Inc. manufactures diagnostic and therapeutic devices for auditory assessment and stimulation, including the Auditory Localizer and Octotoxic Screener for hearing evaluation, as well as the Auditory Stimulator for clinical testing. Their portfolio also includes the System 80 Faceplate-in-the-Ear, a reusable component for hearing aid applications, and the E1 Series Hearing Aid for patient use. Transcutaneous electrical nerve stimulation (TENS) devices are also part of their offerings for pain management.
The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory clearance via the 510(k) pathway. Their products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Auditory Localizer Ref K811772
Regimes: 510(k) Registry: 510(k)Octotoxic Screener Ref K811790
Regimes: 510(k) Registry: 510(k)System 80 Faceplate-In-The-Ear #F1 Ref K822411
Regimes: 510(k) Registry: 510(k)Auditory Stimulator Ref K813557
Regimes: 510(k) Registry: 510(k)E1 Series Hearing Aid Ref K802324
Regimes: 510(k) Registry: 510(k)Tens Device Ref K812138
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Western Advanced Technology, Inc. have in the registry?
The registry currently lists 6 devices for Western Advanced Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Western Advanced Technology, Inc.'s devices?
Among its 6 most recently registered devices, Western Advanced Technology, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Western Advanced Technology, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Western Advanced Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Western Advanced Technology, Inc. in the registry?
The most recently registered devices listed for Western Advanced Technology, Inc. include AUDITORY LOCALIZER, OCTOTOXIC SCREENER, SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 and AUDITORY STIMULATOR.