02/03/2026
𝐍𝐚𝐯𝐢𝐠𝐚𝐭𝐢𝐧𝐠 𝐚 𝐑𝐞𝐜𝐞𝐧𝐭 𝐅𝐃𝐀 𝐂𝐚𝐬𝐞 𝐢𝐧 𝐌𝐢𝐧𝐧𝐞𝐬𝐨𝐭𝐚 & 𝐭𝐡𝐞 𝐓𝐫𝐮𝐭𝐡 𝐘𝐨𝐮 𝐍𝐞𝐞𝐝 𝐭𝐨 𝐊𝐧𝐨𝐰
Recent federal court news regarding an FDA case in Minnesota has brought some critical industry issues to light. As a business owner, certified instructor, and authorized dealer, I’ve always operated on a "compliance-first" basis. This case revolved around altered devices, safety concerns, and fraudulent medical claims, and proves exactly why that matters. If anyone tells you that compliance is “optional”, they are wrong. The consequences of that lie are damaging to our industry, our practitioners, and our patients.
𝐇𝐞𝐫𝐞 𝐢𝐬 𝐭𝐡𝐞 𝐭𝐫𝐮𝐭𝐡, 𝐰𝐡𝐞𝐫𝐞 𝐈 𝐬𝐭𝐚𝐧𝐝, 𝐚𝐧𝐝 𝐰𝐡𝐚𝐭 𝐈 𝐭𝐞𝐚𝐜𝐡 𝐦𝐲 𝐬𝐭𝐮𝐝𝐞𝐧𝐭𝐬:
𝟏. 𝐓𝐚𝐦𝐩𝐞𝐫𝐢𝐧𝐠 𝐢𝐬 𝐈𝐥𝐥𝐞𝐠𝐚𝐥: You do not open the instruments. You do not change batteries yourself. You do not modify internal components. The moment you tamper with an Electro-Acuscope or Electro-Myopulse, it is no longer an FDA-cleared device. You are now using an unapproved therapeutic instrument, and 𝐲𝐨𝐮 𝐜𝐚𝐫𝐫𝐲 𝟏𝟎𝟎% 𝐨𝐟 𝐭𝐡𝐞 𝐥𝐞𝐠𝐚𝐥 𝐥𝐢𝐚𝐛𝐢𝐥𝐢𝐭𝐲. — 𝘛𝘩𝘪𝘴 𝘪𝘯𝘤𝘭𝘶𝘥𝘦𝘴 𝘪𝘧 𝘺𝘰𝘶 𝘩𝘢𝘷𝘦 𝘣𝘦𝘦𝘯 𝘵𝘰𝘭𝘥 𝘵𝘰 𝘤𝘩𝘢𝘯𝘨𝘦 𝘺𝘰𝘶𝘳 𝘰𝘸𝘯 𝘣𝘢𝘵𝘵𝘦𝘳𝘪𝘦𝘴, 𝘰𝘳 𝘢𝘯𝘺 𝘰𝘵𝘩𝘦𝘳 𝘪𝘯𝘵𝘦𝘳𝘯𝘢𝘭 𝘤𝘰𝘮𝘱𝘰𝘯𝘦𝘯𝘵.
𝟐. 𝐓𝐡𝐞 𝐅𝐃𝐀 𝐜𝐥𝐞𝐚𝐫𝐬 𝐭𝐡𝐞𝐬𝐞 𝐢𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭𝐬 𝐚𝐬 𝐚 𝐬𝐲𝐬𝐭𝐞𝐦. This includes the device, the leads/cords, the electrodes and accessories, and the approved conductive solutions. 𝐓𝐡𝐞 𝐦𝐨𝐦𝐞𝐧𝐭 𝐲𝐨𝐮 𝐮𝐬𝐞 𝐚𝐧 𝐮𝐧𝐚𝐩𝐩𝐫𝐨𝐯𝐞𝐝 𝐚𝐜𝐜𝐞𝐬𝐬𝐨𝐫𝐲 𝐨𝐫 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧 (𝐢𝐧𝐜𝐥𝐮𝐝𝐢𝐧𝐠 𝐮𝐧𝐚𝐮𝐭𝐡𝐨𝐫𝐢𝐳𝐞𝐝 𝐨𝐫 𝐡𝐨𝐦𝐞𝐦𝐚𝐝𝐞 𝐞𝐥𝐞𝐜𝐭𝐫𝐨𝐝𝐞𝐬 𝐚𝐧𝐝 𝐔𝐥𝐭𝐫𝐚𝐬𝐨𝐮𝐧𝐝 𝐠𝐞𝐥) 𝐨𝐫 𝐡𝐚𝐯𝐞 𝐚𝐟𝐭𝐞𝐫𝐦𝐚𝐫𝐤𝐞𝐭 𝐩𝐚𝐫𝐭𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐢𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭, 𝐭𝐡𝐞 𝐭𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐢𝐬 𝐧𝐨 𝐥𝐨𝐧𝐠𝐞𝐫 "𝐅𝐃𝐀-𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐭." You have moved into the realm of unauthorized applications. These aspects have ALWAYS been in place since the first FDA approval in 1983, and have remained relevant with every generation of technology (this includes all instruments models of the Acuscope, Myopulse, and Equiscope as it’s a model within this therapy system.)
𝟑. 𝐒𝐜𝐨𝐩𝐞 𝐨𝐟 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞: We provide a 𝐧𝐨𝐧-𝐢𝐧𝐯𝐚𝐬𝐢𝐯𝐞 𝐨𝐩𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐩𝐚𝐢𝐧 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐰𝐢𝐭𝐡 𝐧𝐞𝐮𝐫𝐨𝐦𝐮𝐬𝐜𝐮𝐥𝐚𝐫 𝐚𝐧𝐝 𝐦𝐮𝐬𝐜𝐮𝐥𝐨𝐬𝐤𝐞𝐥𝐞𝐭𝐚𝐥 𝐜𝐨𝐧𝐝𝐢𝐭𝐢𝐨𝐧𝐬 𝐎𝐍𝐋𝐘. We do not and cannot "treat" internal pathologies or systemic diseases. Providing training or guidance to others to do so, or making false claims to appease a social media base or a client’s trust isn’t just unethical, it is a 𝐟𝐞𝐝𝐞𝐫𝐚𝐥 𝐯𝐢𝐨𝐥𝐚𝐭𝐢𝐨𝐧.
𝟒. 𝐓𝐡𝐞 𝐀𝐧𝐢𝐦𝐚𝐥 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐌𝐲𝐭𝐡: Some believe FDA guidelines don't apply to equine or canine work. 𝐓𝐡𝐢𝐬 𝐢𝐬 𝐅𝐀𝐋𝐒𝐄. 𝐓𝐡𝐞 𝐅𝐃𝐀 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐟𝐨𝐥𝐥𝐨𝐰 𝐭𝐡𝐞 𝐢𝐧𝐬𝐭𝐫𝐮𝐦𝐞𝐧𝐭, 𝐧𝐨𝐭 𝐭𝐡𝐞 𝐩𝐚𝐭𝐢𝐞𝐧𝐭. 𝘛𝘩𝘪𝘴 𝘸𝘢𝘴 𝘱𝘦𝘳𝘴𝘰𝘯𝘢𝘭𝘭𝘺 𝘷𝘦𝘳𝘪𝘧𝘪𝘦𝘥 𝘣𝘺 𝘵𝘩𝘦 𝘍𝘋𝘈 𝘢𝘨𝘦𝘯𝘵𝘴.
𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐲
These guidelines aren't just my professional opinion — 𝐭𝐡𝐞𝐲 𝐚𝐫𝐞 𝐞𝐬𝐭𝐚𝐛𝐥𝐢𝐬𝐡𝐞𝐝 𝐬𝐭𝐚𝐭𝐞 𝐚𝐧𝐝 𝐟𝐞𝐝𝐞𝐫𝐚𝐥 𝐥𝐚𝐰𝐬. I choose to be 100% transparent with my students and customers because your career and your patients' safety are of the utmost importance, and should be that way with anyone who you work with. Misinformation in this industry is rampant. 𝐁𝐞𝐢𝐧𝐠 𝐭𝐨𝐥𝐝 𝐛𝐲 𝐚 𝐭𝐡𝐢𝐫𝐝 𝐩𝐚𝐫𝐭𝐲 𝐭𝐡𝐚𝐭 𝐲𝐨𝐮 𝐚𝐫𝐞 '𝐜𝐥𝐞𝐚𝐫𝐞𝐝’ 𝐨𝐫 𝐜𝐚𝐧 𝐛𝐲𝐩𝐚𝐬𝐬 𝐭𝐡𝐞 𝐥𝐚𝐰𝐬 𝐭𝐨 𝐭𝐫𝐞𝐚𝐭 𝐡𝐮𝐦𝐚𝐧𝐬 𝐝𝐨𝐞𝐬 𝐧𝐨𝐭 𝐬𝐮𝐩𝐞𝐫𝐬𝐞𝐝𝐞 𝐬𝐭𝐚𝐭𝐞 𝐚𝐧𝐝/𝐨𝐫 𝐟𝐞𝐝𝐞𝐫𝐚𝐥 𝐥𝐚𝐰. No instructor or distributor has the authority to bypass your state’s medical board. If you don't hold the proper medical license, credentials, or meet the legal requirements of your state then you are operating outside of the law, 𝐩𝐞𝐫𝐢𝐨𝐝. This is not solely about the level of efficacy with these instruments, but rather about safety standards and the level of professionalism that is needed in our industry from a legal perspective.
— 𝐈𝐟 𝐲𝐨𝐮 𝐚𝐥𝐫𝐞𝐚𝐝𝐲 𝐦𝐞𝐞𝐭 𝐭𝐡𝐞 𝐥𝐞𝐠𝐚𝐥 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐨𝐟 𝐲𝐨𝐮𝐫 𝐬𝐭𝐚𝐭𝐞 𝐚𝐧𝐝 𝐜𝐨𝐧𝐭𝐢𝐧𝐮𝐞 𝐭𝐨 𝐫𝐞𝐦𝐚𝐢𝐧 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐰𝐢𝐭𝐡𝐢𝐧 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐠𝐮𝐢𝐝𝐞𝐥𝐢𝐧𝐞𝐬, 𝐲𝐨𝐮 𝐡𝐚𝐯𝐞 𝐧𝐨𝐭𝐡𝐢𝐧𝐠 𝐭𝐨 𝐛𝐞 𝐜𝐨𝐧𝐜𝐞𝐫𝐧𝐞𝐝 𝐚𝐛𝐨𝐮𝐭. For those looking to enter this industry, we take pride in mentoring you through these important details, ensuring you have a solid foundation to start your journey the right way.
𝐀 𝐏𝐞𝐫𝐬𝐨𝐧𝐚𝐥 𝐍𝐨𝐭𝐞 𝐨𝐧 𝐓𝐡𝐢𝐬 𝐋𝐞𝐠𝐚𝐥 𝐏𝐫𝐨𝐜𝐞𝐬𝐬
Because of my position in the industry, I was subpoenaed as a witness in this case. While a subpoena can sound intense, it was actually a powerful validation of my practice. I was able to assist federal special agents and investigators without question because my records, my business conduct, and my equipment are 100% compliant.
I also took that opportunity to consult with the FDA agents to ensure my training protocols and practices within our 𝐀𝐧𝐢𝐦𝐚𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐒𝐲𝐬𝐭𝐞𝐦𝐬 (𝐀𝐓𝐒) program, and my 𝐏.𝐑.𝐎.𝟏𝟏® 𝐏𝐫𝐨𝐠𝐫𝐚𝐦 (my professional sports division through 𝐄𝐥𝐢𝐭𝐞 𝐀𝐭𝐡𝐥𝐞𝐭𝐢𝐜 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐚𝐧𝐭𝐬) are compliant. My commitment to doing things the right way and remaining compliant was recognized and reaffirmed. It is my responsibility to every student, customer, client, and patient that I uphold the level of professionalism and compliance that is required of me in this position.
𝐀 𝐏𝐚𝐭𝐡 𝐅𝐨𝐫𝐰𝐚𝐫𝐝
I am sharing this for educational purposes, and as a long overdue wake-up call. Whether you have unknowingly crossed the line by trusting misguided advice, or you’ve been tempted by the 'shortcuts' of unapproved accessories and false claims, 𝐈 𝐮𝐫𝐠𝐞 𝐲𝐨𝐮 𝐭𝐨 𝐬𝐭𝐨𝐩 𝐚𝐧𝐝 𝐫𝐞𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫. Don't wait for a legal issue to arise.
If you are concerned about your equipment’s calibration or the guidance you’ve received, we are, and always have been, here to help — without judgment. We have helped numerous practitioners by:
• Verifying serial numbers with the manufacturer.
• Ensuring instruments are properly calibrated and functioning (not altered).
• Providing training to help you work safely within your proper scope of practice.
Ultimately, if anyone truly has the best interests of the animals at heart, our first priority must be their safety. Professionalism is more than just skill, it is the integrity to remain compliant with the standards that protect our industry and those we care for. We can collectively do right by this technology, our clients, and our professional future within this industry. 𝐎𝐮𝐫 𝐚𝐧𝐢𝐦𝐚𝐥𝐬 𝐝𝐞𝐬𝐞𝐫𝐯𝐞 𝐭𝐡𝐚𝐭.
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