FDA Approved versus FDA Cleared in the World of EMS
There are far more compelling topics to blog about than government regulation. However, as more EMS personal trainers and companies are sprouting up, we are beginning to see EMS equipment knockoffs, often accompanied by wild marketing claims. So, let’s explore the regulations.
When it comes to devices like whole-body electrical muscle stimulators (WB-EMS), understanding the distinction between FDA approval and FDA clearance is essential to ensure this fitness niche remains safe for everyone. This blog explores the key differences between these regulatory pathways and sheds light on how certain EMS companies achieved FDA clearance.
FDA Approval vs. FDA Clearance:
- FDA Approval:
FDA approval is a rigorous process reserved for high-risk medical devices. These devices typically sustain or support human life, are implanted, or present a potential risk of illness or injury. The approval process involves extensive clinical trials, comprehensive data analysis, and a thorough examination of the device’s safety and effectiveness. This process is usually measured in years.
Obtaining FDA approval is a time-consuming and resource-intensive endeavor. Manufacturers must submit a pre-market approval (PMA) application, which includes detailed information on the device’s design, manufacturing processes, preclinical and clinical data, and more. The FDA then reviews this information to determine if the benefits of the device outweigh its risks.
- FDA Clearance:
FDA clearance, on the other hand, is for lower-risk devices categorized under Class I or Class II. These devices pose fewer potential risks and are subject to a less stringent review process. Clearance is typically granted through the 510(k) pre-market notification pathway, where manufacturers demonstrate that their device is substantially equivalent to an existing legally marketed device. This process is usually measured in months, although it may take a year or even longer
The 510(k) submission includes information about the device’s intended use, technological characteristics, and performance data. The FDA reviews this information to ensure that the new device is as safe and effective as the predicate device it references.
WB-EMS and FDA Clearance:
Whole-body electrical muscle stimulators, designed to enhance muscle performance through electrical impulses, fall into the Class II medical device category. Achieving FDA clearance for WB-EMS involves demonstrating that the device is substantially equivalent to existing devices with established safety and efficacy profiles.
The process begins with the manufacturer preparing a 510(k) submission, outlining the device’s features, intended use, and performance data. The FDA then reviews this submission and determines whether the device meets the necessary criteria for clearance. For WB-EMS, demonstrating safety, efficacy, and the absence of undue risks are crucial components of the clearance process.
As of the writing of this blog, these are the only WB-EMS devices we are aware of that are FDA-cleared for use in the U.S.: Wiemspro, XBody, Miha Bodytec, E-Fit, Katalyst, I-motion, Visionbody, Gnesis, and Neuro20.
Other localized EMS devices such as Compex are also FDA-cleared but they are usually for personal use on a single joint. You can read more about localized vs. whole-body electrical muscle stimulation in our previous blog.
If you are thinking about trying a WB-EMS training session, we highly recommend asking which manufacturer provided the equipment and confirm it is FDA-cleared. Any reputable EMS trainer or company should be able to provide you with a copy of their 510(k) FDA document upon request. If they refuse, head for the exits!
If you want to learn more about EMS, book a free consultation with me here: https://calendly.com/conradfitness/30min. You can also make an appointment to book an intro session at our Costa Mesa studio.
Conrad
Managing Director
Bodybuzz
Bodybuzz combines Certified Personal Training with Electrical Muscle Stimulation, giving your body a deeper, safer, and more effective workout. 20 minutes twice a week is all it takes!
Our personal trainers will guide you through a custom EMS workout designed specifically for you. Whether you’re looking to build strength, lose weight, get toned, or recover from an injury or illness, we offer a safe, low-impact solution to help get you there.
EMS has now been FDA-cleared for use in the US and we are proud to be one of the first companies to introduce this technology. This full-body workout uses a special muscle stimulating suit that sends low-level impulses to your major muscle groups to trigger muscle contractions. It’s a unique sensation that is painless and invigorating. EMS workouts are designed to achieve optimal conditioning, burn fat, develop strength, build muscle, tighten skin, combat cellulite, jump-start your metabolism, and restore your body’s natural balance.