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FDA 510(k)

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)

N.º K: K252531 · 2026-03-02

SolicitanteMyofunctional Research Co.
Fecha de decisión2026-03-02
Código de productoLRK
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is the device name listed in this FDA 510(k) record. The listed applicant is Myofunctional Research Co.. It received FDA 510(k) clearance on 2026-03-02 under 510(k) number K252531. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is a medical device that received FDA 510(k) clearance on 2026-03-02. The listed applicant is Myofunctional Research Co.. The 510(k) number is K252531.

When did Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) receive FDA 510(k) clearance?

Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) received FDA 510(k) clearance on 2026-03-02, under 510(k) number K252531.

Who is the listed applicant for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

The FDA 510(k) record lists Myofunctional Research Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)?

The FDA product code for Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) is LRK.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: LRK)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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