Greystone Ip, Ltd.
IE Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Soundly Anti Snoring Device Ref K220330
What Greystone Ip, Ltd. makes
Greystone Ip, Ltd. manufactures the Soundly Anti Snoring Device, a medical device designed to reduce snoring through targeted airway support.
The company’s portfolio is regulated under FDA’s Class II device classification and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does Greystone Ip, Ltd. manufacture?
Greystone Ip, Ltd. specializes in the Soundly Anti Snoring Device, which is designed to help reduce snoring by providing targeted airway support. This device falls under the category of respiratory therapy products, addressing a common sleep-related issue.
Where is Greystone Ip, Ltd. based, and how does this affect its regulatory oversight?
Greystone Ip, Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The Soundly Anti Snoring Device is classified as a Class II device, indicating moderate risk and requiring compliance with FDA’s 510(k) pathway for market authorization.
Which regulatory registries or databases list Greystone Ip, Ltd.’s devices?
Greystone Ip, Ltd.’s devices, including the Soundly Anti Snoring Device, are listed in the FDA’s 510(k) registry. This pathway is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, ensuring compliance with U.S. regulatory requirements.
How are Greystone Ip, Ltd.’s devices classified under U.S. regulations?
The Soundly Anti Snoring Device is classified as a Class II medical device by the FDA. This classification is based on the device’s intended use and potential risk level. Class II devices require special controls in addition to general controls to ensure safety and effectiveness, and they must go through the 510(k) premarket notification process.
Information
- Country
- IE