Compliance & Safety Notices

HemWell MD’s FDA Approval Compliance

HemWell MD is committed to promoting our Hemwellectomy device in accordance with FDA regulations and guidelines. Consistent with our FDA approval, our promotional materials truthfully reflect the device’s intended use and capabilities. This commitment extends to our online marketing and social media platforms, ensuring that all information about the Hemwellectomy device is accurate, non-misleading, and in full compliance with the FDA’s approved labeling and claims, as stipulated in our Premarket Approval (PMA) .

HemWell MD Field Safety Notice

Dear Valued Customer,
At HemWell MD, we continuously monitor our products to ensure their safety and reliability. In our vigilant product surveillance, should we identify any potential issues that could affect the Hemwellectomy device’s performance, we will promptly provide:
A detailed description of the identified problem and the circumstances under which it may occur.
Recommended actions for users to avoid the problem or minimize its impact.
Planned actions by HemWell MD to resolve the issue effectively.
For further information or support regarding this, please contact our representative at info@hemwellmd.com I 8137556170.

Stark Law Compliance at HemWell MD

HemWell MD adheres strictly to the Stark Law regulations, ensuring that our practices in physician referrals and interactions with healthcare entities comply with legal and ethical standards.We maintain transparency in all our operations, especially in areas concerning Medicare and Medicaid patient referrals, to avoid conflicts of interest and maintain the integrity of our services.