The Difference Between FDA Cleared Versus Approved

Clarifying the terminology: What it means that Alpha-Stim is FDA Cleared for anxiety, insomnia, and pain.

When researching medical devices like Alpha-Stim, you will often see the term "FDA Cleared." It's important to understand what this means and how it differs from "FDA Approved," as these terms are frequently misunderstood.

FDA Approved vs. FDA Cleared

The FDA generally uses the term "Approved" for Class III medical devices (the highest risk category, like pacemakers) and new pharmaceutical drugs. To get "Approval," a company must prove the product's safety and efficacy through extensive clinical trials.

"FDA Cleared" is the designation used for Class I and Class II medical devices, which are considered lower risk. Alpha-Stim falls into this category. To get "Cleared," a company must demonstrate that the device is "substantially equivalent" to another legally marketed device that is already proven to be safe and effective.

What It Means for Alpha-Stim

Alpha-Stim is FDA Cleared for the treatment of anxiety, insomnia, and pain. This means the FDA has reviewed the device and determined it is safe and effective for these specific uses. The clearance is based on the substantial body of clinical evidence—over 100 studies over 40 years—demonstrating its safety profile and therapeutic benefits.

So, while the term is "Cleared" rather than "Approved" based on the FDA's classification system for devices, it carries the weight of FDA regulation and signifies that Alpha-Stim is a recognized, legitimate medical treatment.