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2 VitalSleep Mouthpiece - 2 Sleep Masks, 2 Cleaning Brushes
2 VitalSleep Mouthpiece - 2 Sleep Masks, 2 Cleaning Brushes
$ 299.95

Complaint Form

Device Complaint Investigation Form

🔧 Device Complaint Investigation Form

Complies with 21 CFR §820.198

1. Complaint Identification


2. Complainant Information

3. Device Information

4. Complaint Details


5. FDA MDR Evaluation

6. Investigation Determination

7. Investigation Record

8. Communication with Complainant

9. Accessibility Compliance

Final Review and Signature