Jiangmen Shengke Hardware Products Co., Ltd

Jiangmen Shengke Hardware Products Co., Ltd specializes in external manual massagers for home use, specifically stainless steel facial ice globes. These devices are designed for manual application to provide facial relaxation and cooling as part of skincare routines. The focus is on Class I devices intended for non-invasive, low-risk applications.

The company is based in the United States, which means its devices are subject to FDA regulations. Since the products fall under Class I classification (the lowest risk category), they typically require less stringent premarket review, though compliance with FDA’s registration and listing requirements—such as UDI assignment—remains mandatory for market distribution.

Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing is critical because UDIs enable transparent tracking of medical devices throughout their lifecycle, ensuring traceability for regulatory purposes, recalls, and post-market surveillance. Listing also helps healthcare providers and users verify the device’s identity and compliance status.

The company’s devices are classified as FDA Class I, which means they pose minimal potential risk to users. This classification is based on factors like the device’s intended use (e.g., manual facial massage) and lack of invasive or life-supporting functions. Class I devices generally require registration and listing with the FDA but may not need premarket approval, though compliance with general controls (e.g., labeling, manufacturing practices) is still required.