# China NMPA Product Recall - Specific Electromagnetic Wave (TDP) Therapy Device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-hualun-hongli-industrial-co-ltd/a0c75167-13a0-4828-b1a6-89e7c5da5cdd/
Source feed: China

> China NMPA product recall for Specific Electromagnetic Wave (TDP) Therapy Device by Chongqing Hualun Hongli Industrial Co., Ltd. published January 22, 2020. Recall level: Level 3. On January 3, 2020, Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III rec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Hualun Hongli Industrial Co., Ltd. voluntarily recalls certain electromagnetic wave therapy devices.
- Company Name: Chongqing Hualun Hongli Industrial Co., Ltd.
- Publication Date: 2020-01-22
- Product Name: Specific Electromagnetic Wave (TDP) Therapy Device
- Recall Level: Level 3
- Recall Reason: A certain electromagnetic wave therapy device manufactured by our company on January 9, 2018, does not meet the requirements for "voltage and/or energy limits". In order to effectively control the defective products and eliminate safety hazards, our company has decided to implement a voluntary recall.
- Discovering Company: Chongqing Hualun Hongli Industrial Co., Ltd.
- Manufacturing Company: Chongqing Hualun Hongli Industrial Co., Ltd.
- Summary: On January 3, 2020, Chongqing Hualun Hongli Industrial Co., Ltd. initiated a voluntary Class III recall of specific electromagnetic wave therapy devices, a measure subsequently publicized by the National Medical Products Administration (NMPA) on January 22, 2020. The recall pertains to 65 units of their CQH-25A model, batch number 1801041, which were produced on January 9, 2018. These devices are intended for adjunctive treatment of soft tissue injuries, cervical spondylosis, lumbar spondylosis, and arthritis. The core reason for this recall is that the affected electromagnetic wave therapy devices do not comply with essential "voltage and/or energy limitations" requirements, thereby presenting a potential safety hazard to users. Operating within the NMPA's stringent regulatory framework for medical devices, the company has undertaken this corrective action to proactively manage defective products and mitigate risks. As part of the required actions, Chongqing Hualun Hongli Industrial Co., Ltd. is responsible for distributing "Medical Device Recall Notices" to all its sales units. These notices instruct medical institutions and operating units to promptly implement the outlined procedures to address the recalled products. This comprehensive approach underscores the manufacturer's commitment to product safety and adherence to national medical device standards, ensuring public health protection.

Company: https://www.globalkeysolutions.net/companies/chongqing-hualun-hongli-industrial-co-ltd/078a5e65-54be-455e-926a-e5fbe959ce6b/