China NMPA Product Recall - Specific electromagnetic wave therapy device

The National Medical Products Administration (NMPA) published a voluntary Class III recall notice on October 22, 2020, concerning Chongqing Runyang Medical Device Co., Ltd.'s Specific Electromagnetic Wave Therapy Devices (Registration No.

Chongqing Runyang Medical Device Co., Ltd. is voluntarily recalling specific electromagnetic wave therapy devices (Registration No.: 渝械注准20162260046) due to non-compliance with product technical requirements. The recall, initiated on October 16, 2019, was prompted by the devices' input power exceeding the standard. The actual measured input power was 259.8VA, surpassing the maximum allowable 253VA (rated 230VA + 10%) by 6.8VA (1.2% over standard). This Class III recall, indicating low risk of adverse health consequences, affected 60 units of model TDP-CQ-28 from batch 28803021. Chongqing Runyang Medical Device Co., Ltd. replaced and returned 16 recalled units to the distributor by November 14, 2019. The company submitted a Medical Device Recall Event Report Form on December 24, 2019, to the Provincial Food and Drug Administration, with the NMPA publicizing the recall on October 22, 2020.