Are Joovv devices registered with the FDA?

The Joovv Go, Mini and Solo have been registered with the FDA as Class II medical devices and fall under the product code ILY. ILY devices are part of a special controls category that is subject to certain limitations but are exempt from pre-market notification requirements under the Food and Drug Administration Modernization Act of 1997 (FDAMA) or the 21st Century Cures Act of 2016 (Cures Act). The FDA believes that these exemptions will relieve manufacturers like (Joovv) from the need to submit pre-market notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues.

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