Xiamen Healthpal Electronic Co., Ltd

Xiamen Healthpal Electronic Co., Ltd produces three primary categories of devices: adhesive infrared reflective phototherapy skin patches for treatment, handheld deep-tissue electromagnetic stimulators, and leg protectors designed to minimize friction and impact. Additionally, they manufacture an air compression leg massager, specifically the model FE-7204B. These devices are developed for targeted therapeutic or supportive applications.

The company is based in the United States. This location is relevant for regulatory compliance and reporting, as it influences which regulatory bodies oversee its devices and where they may be marketed.

Devices from Xiamen Healthpal Electronic Co., Ltd are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track Class II devices, which require specific regulatory pathways to ensure safety and effectiveness before market authorization.

All devices produced by Xiamen Healthpal Electronic Co., Ltd fall under Class II classification. This classification indicates moderate regulatory oversight, requiring manufacturers to demonstrate that their devices are substantially equivalent to legally marketed predicates or meet specific performance standards to ensure safety and effectiveness.