Protecting Your Safety and Well-Being with Genuine Biomat Products

September 29, 2023

Protecting Your Safety and Well-Being with Genuine Biomat Products

Along with the rise of Biomat popularity, some copycat companies have begun producing cheaper imitation versions of the Original Richway Biomat

In recent times, we have noticed a concerning trend where certain companies have chosen to prioritize cost-cutting measures over the development and manufacturing of high-quality products with established therapeutic efficacy.

Instead of investing in advanced technology and research, these companies seem to focus their efforts on marketing low-cost alternatives that pose grave risks to your well-being.

What worries us most is the use of substandard components by these copycat companies, including thin, low-quality plastic for their heating elements. This careless approach raises significant safety concerns, and we fear that a major safety incident may be just around the corner.

As a responsible and proactive measure, we strongly urge these Biomat copycat companies to, at the very least, pursue minimal electrical safety certifications such as UL or CSA, even if full compliance with all U.S. medical device regulations proves challenging and costly. Acquiring these certifications represents a fundamental safety step to prevent potential accidents and safeguard your health.

To help you better understand the disparities between Biomat and these copycat products, we have prepared informative video links:

·         Short Video Link (Biomat vs. Copycats S1)

·         Full Video Link (Biomat vs. Copycats)

In the United States and Canada, selling far-infrared thermal devices necessitates a multitude of safety certifications, including:

  • Good Manufacturing Practices (GMP)
  • ISO 13485 or the Medical Device Single Audit Program (MDSAP) for production system management
  • National Recognized Testing Laboratory (NRTL) electrical safety certifications (UL, CSA, ETR)
  • Federal Communications Commission (FCC)
  • Electromagnetic safety certifications (FC)
  • Unique Device Identification (UDI) for tracking and managing medical devices
  • 510(k) Premarket Notification for product clearance
  • Corrective and Preventive Action (CAPA) for product safety management.

These certifications are vital prerequisites for importing medical devices into the United States, yet many Biomat copycat companies continue to import and sell their products without obtaining any certifications.