Regulatory Affairs Work
Novexa SoundBudz
• 510 (k) Substantial Equivalence
• Assignment
This Traditional 510(k) Premarket Notification is submitted for the SoundBudz Hearing Aid, a self-fitting air conduction hearing aid intended to amplify sound for adults with mild to moderate hearing impairment.
WheelyChair2000 Recall
• Compliance / CAPA
• Global Field Action
At Las Flores MeDevices, a report was made by a physician on February 5th , 2025, that a patient was injured when a Wheely Chair 2000 power wheelchair tipped over while descending a curb ramp at low speed, causing the patient an injury that required 21 stitches.