Diacore— 510(k) K253926

Diacore was filed under product code NGX — Physical Medicine panel, a code that covers non-implantable rehabilitation and therapeutic modality devices (TENS units, therapeutic ultrasound, some diagnostic muscle-assessment hardware). The device_name "Diacore" is generic and the filing record provides no further product description.

Physical Medicine panel, Traditional 510(k). NGX submissions come from a mix of Asian manufacturers, particularly Korean and Chinese companies producing consumer-adjacent rehab equipment that crosses the medical-device line.

ShenB Co. files from Seoul. Four-month review clock — short for Traditional 510(k), typical for NGX where predicate chains are well-established and the technological complexity is moderate.