HEALY INTERNATIONAL CERTIFICACIONES, APROBACIONES Y AUTORIZACIONES DE PRODUCTOS SANITARIOS
Estados Unidos de América
Como dispositivo médico con aplicaciones adicionales para el bienestar.
Healy con REF 0006 ha sido autorizado por la FDA como dispositivo médico en los Estados Unidos de América para las siguientes indicaciones:
– Alivio temporal del dolor asociado a los músculos doloridos del hombro, la cintura, la espalda, los brazos y las piernas causado por el ejercicio o las actividades domésticas normales; alivio sintomático y tratamiento del dolor crónico y persistente; y alivio del dolor asociado a la artritis.
En los Estados Unidos de América, Healy está disponible con REF 0006 como dispositivo médico y también contiene programas de bienestar.
HEALY INTERNATIONAL CERTIFICACIONES, APROBACIONES Y AUTORIZACIONES DE PRODUCTOS SANITARIOS
Unión Europea, Suiza y Noruega
Como producto sanitario sólo para aplicaciones médicas y también como producto no sanitario sólo para aplicaciones de bienestar.
Healy con número de referencia REF 0006 es un producto sanitario en todos los países de la Unión Europea con las siguientes indicaciones:
– Tratamiento del dolor (dolor crónico, fibromialgia, dolor del sistema esquelético, migraña).
– Enfermedades mentales como depresión, ansiedad y trastornos del sueño asociados.
En Europa, Healy está disponible como dispositivo médico con REF 0006, que contiene únicamente los programas según las indicaciones, y además como Healy Wellness, un dispositivo no médico con REF 0009, que contiene únicamente programas de bienestar.
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