A Mano Products, Ltd.
GB Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
A Mano Tongue Cleanser Ref K932839
What A Mano Products, Ltd. makes
A Mano Products, Ltd. manufactures the A MANO Tongue Cleanser, a manual device designed for oral hygiene to remove debris and bacteria from the tongue surface.
The company’s product is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does A Mano Products, Ltd. manufacture?
A Mano Products, Ltd. specializes in manual oral hygiene devices. Specifically, the company produces the A MANO Tongue Cleanser, which is designed to help users remove debris and bacteria from the tongue surface.
Where is A Mano Products, Ltd. based?
A Mano Products, Ltd. is headquartered in the United States. The company’s location is relevant for understanding its regulatory and operational context.
How are the devices manufactured by A Mano Products, Ltd. classified in the US?
The A MANO Tongue Cleanser is classified as a Class I medical device under US regulations. This classification is typically assigned to devices posing minimal risk to users, such as low-risk manual devices, and often requires less stringent premarket review compared to higher-risk categories.
Are the devices from A Mano Products, Ltd. listed in any regulatory registries?
Yes, the A MANO Tongue Cleanser is listed under the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to legally marketed predicates, demonstrating safety and effectiveness through comparative analysis rather than full clinical trials.
Information
- Country
- GB