Turtle Beach Corporation is one of 15069 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Turtle Beach Corporation - FDA 510(k) Cleared Devices
Recent clearances: HyperSound Tinnitus Module
1
Total
1
Cleared
0
Denied
Turtle Beach Corporation, is a gaming audio and controller manufacturer based in San Diego, US. The company specializes in wireless gaming headsets, modular controllers, and premium audio equipment for competitive and casual gamers across multiple platforms.
Turtle Beach has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Ear, Nose, Throat devices, with its cleared device being the HyperSound Tinnitus Module. The clearance was granted in 2016 and represents the company's only FDA 510(k) submission on record. Turtle Beach has been inactive in the FDA 510(k) clearance process for more than five years and should be treated as a historical regulatory record.
While the company's primary business focuses on gaming audio peripherals and controllers, its single FDA-cleared device reflects a specialized medical application in tinnitus management. Explore the device clearance details, product codes, and submission dates in the database records below.
FDA 510(k) Regulatory Record - Turtle Beach Corporation
1 devices