Lifesounds, Inc.
Country not established
- Devices
- 1
What Lifesounds, Inc. makes
Lifesounds, Inc. manufactures customizable in-ear monitoring devices designed for hearing protection and sound amplification in occupational or recreational settings. These devices are tailored to individual hearing needs and environments, balancing noise attenuation with clear audio transmission. They are primarily used in industries where prolonged exposure to loud sounds is common, such as construction or music production.
The company’s portfolio is regulated under Class I medical devices in the U.S., with devices listed via the FDA’s 510(k) pathway. Products are tracked in the FDA’s regulatory database, ensuring compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Lifesound Custom Ite Ref K862050
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lifesounds, Inc. have in the registry?
The registry currently lists 1 device for Lifesounds, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lifesounds, Inc.'s devices?
Among its 1 most recently registered device, Lifesounds, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Lifesounds, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Lifesounds, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Lifesounds, Inc. in the registry?
The most recently registered devices listed for Lifesounds, Inc. include LIFESOUND CUSTOM ITE.