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510(k) Data Aggregation
K Number
K220938Device Name
Nova HD+
Manufacturer
Date Cleared
2023-08-22
(509 days)
Product Code
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Aura Wellness, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Device Description
The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance.
The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use.
In addition to the main control unit, the Nova HD+ includes a large loop coil applicator (coils) which allow the operator to administer optimal treatment to the desired anatomical part of the body.
The device contains firmware that controls the user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.
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