Clearance: When a medical device is cleared, this means it has undergone a 510(k) submission, which FDAhas reviewed and provided clearance.
Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.
Herabeat is a Class IIa medical device and does not achieve its result through chemical action with or on the body.
HMD General Discussion, page-4
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