# China NMPA Product Recall - Specific electromagnetic wave therapy device

Source: https://www.globalkeysolutions.net/records/china_product_recall/chongqing-runyang-medical-devices-co-ltd/56d38c12-bc1c-4c68-b073-78a2addaef04/
Source feed: China

> China NMPA product recall for Specific electromagnetic wave therapy device by Chongqing Runyang Medical Devices Co., Ltd. published April 12, 2021. Recall level: Level 3. The National Medical Products Administration (NMPA) announced on April 12, 2021, a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Chongqing Runyang Medical Devices Co., Ltd. voluntarily recalls certain electromagnetic wave therapy devices.
- Company Name: Chongqing Runyang Medical Devices Co., Ltd.
- Publication Date: 2021-04-12
- Product Name: Specific electromagnetic wave therapy device
- Recall Level: Level 3
- Recall Reason: 1. Product Technical Requirements: Input Power: Rated power 230VA, Measured value ±≤ Rated power × (1 + 10%) = 253VA 2. Actual Measured Data: 259.8VA, exceeding the standard by 6.8VA (1.2% over the standard)
- Discovering Company: Chongqing Runyang Medical Devices Co., Ltd.
- Manufacturing Company: Chongqing Runyang Medical Devices Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on April 12, 2021, a voluntary Class III recall initiated by Chongqing Runyang Medical Device Co., Ltd. for specific Electromagnetic Wave Therapy Devices (Model TDP-CQ-28). The recall stemmed from product non-compliance, specifically regarding the device's input power. Investigations revealed that the affected devices exceeded their stipulated technical requirements. The rated input power was 230VA, with an allowable range up to 253VA. However, actual measurements showed a reading of 259.8VA, surpassing the standard by 6.8VA. This constituted a 1.2% exceedance of the technical specification. In response, Chongqing Runyang Medical Device Co., Ltd. issued a recall notice on October 16, 2019, targeting batch number 28803021, which comprised 60 units sold in China. By November 14, 2019, 16 units from the affected batch were successfully recalled. All these recalled devices were subsequently replaced and returned to the respective distributor, as detailed in the Medical Device Recall Event Report Form submitted on December 24, 2019. This proactive measure ensured the resolution of the non-compliant products in accordance with NMPA's regulatory expectations.

Company: https://www.globalkeysolutions.net/companies/chongqing-runyang-medical-devices-co-ltd/922a9d16-92dc-43a4-a5f0-8cebb333c029/