Health Plus (Shanghai) International Co., LTD

Health Plus (Shanghai) International Co., Ltd. specializes in single-use hot and cold therapy packs. These devices are intended for temporary pain relief and inflammation management, typically used by consumers over-the-counter to apply controlled thermal therapy to targeted body areas.

Health Plus (Shanghai) International Co., Ltd. has a US-based presence, which allows it to align its manufacturing and distribution with US regulatory requirements. This is particularly relevant for its Class I devices, as compliance with FDA standards is a key consideration for low-risk products like thermal therapy packs.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion ensures traceability and transparency for Class I medical devices, which are generally considered low-risk but still subject to regulatory oversight.

Health Plus (Shanghai) International Co., Ltd.’s products fall under FDA’s Class I classification. This classification applies to devices that pose minimal risk to users, such as single-use hot and cold therapy packs, which are designed for temporary, non-invasive therapeutic applications without active controls.