Myoaligner Appliance
K-Number: K230548 · 2024-02-02
ApplicantMyohealth Technologies, LLC
Decision Date2024-02-02
Product CodeMQC
DecisionSubstantially Equivalent
Device Summary
Myoaligner Appliance is a medical device manufactured by Myohealth Technologies, LLC. It received FDA 510(k) clearance on 2024-02-02 under approval number K230548. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Myoaligner Appliance?
Myoaligner Appliance is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Myohealth Technologies, LLC. The 510(k) number is K230548.
When was Myoaligner Appliance approved by the FDA?
Myoaligner Appliance received FDA 510(k) clearance on 2024-02-02, under approval number K230548.
What company makes Myoaligner Appliance?
Myoaligner Appliance is manufactured by Myohealth Technologies, LLC.
What is the FDA product code for Myoaligner Appliance?
The FDA product code for Myoaligner Appliance is MQC.
Related Devices (Code: MQC)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.