Myoaligner Appliance— 510(k) K230548

Substantially Equivalent

Myohealth Technologies, LLC

FDA 510(k) clearance K230548 for Myoaligner Appliance, Substantially Equivalent on 2024-02-02. Applicant: Myohealth Technologies, LLC.

Clearance details

Applicant
Myohealth Technologies, LLC
Product code
Code MQC
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Portland, OR, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQC

product code MQC
Injury
377
Total
377

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.