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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-09-02NAINo action indicatedCC Wellness, LLC0
2021-09-02NAINo action indicatedCC Wellness, LLC0
2018-03-21VAIVoluntary action indicatedCC Wellness, LLC5
2018-03-21VAIVoluntary action indicatedCC Wellness, LLC5
2014-01-30VAIVoluntary action indicatedCC Wellness, LLC7
2014-01-30VAIVoluntary action indicatedCC Wellness, LLC7
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