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Disclaimer: There is no guarantee that OAK will be manufactured or that regulatory permission (such as FDA approval or clearance) that may be required to distribute OAK commercially will be granted. At the current time, there are neuromodulation devices intended for wellness that are commercially available without a prescription and are not regulated as medical devices, however the regulatory and prescription requirements for such devices may change. Regulatory permission to distribute OAK, should it be granted, may not be granted until late 2024 or 2025, and if granted, a prescription may be required to obtain OAK.

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