MalfunctionQDA

FITVII

Received Nov 29, 2024

Report MW5163039 · MDR key 20822609

Device

Generic name

Electrocardiograph Software For Over-the-counter Use

Manufacturer

Fitviii

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

HTTPS://FITVII.COM/PRODUCTS/FITVII-NEW-POWERFUL-SMARTWATCH-ECG-WITH-HEART-RATE-BLOOD-PRESSURE-MONITOR-EKG-BLOOD-SUGAR-STRESS-TESTING THIS PRODUCT IS BEING SOLD IN THE US TO PATIENTS, FALSELY REPORTING TO TRACK DIABETES AND BLOOD PRESSURE.