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FDA approved vs FDA cleared: What’s the Difference?

FDA approved vs FDA cleared: What’s the Difference?

December 29, 2018

Many of our patients are surprised when we tell them that the various treatments they have received for their chronic overuse injuries are not actually FDA approved. The terminology can be confusing, even for doctors, and the marketing done for these non-FDA approved devices by third-parties often push the legal and ethical limits. But, with just a bit of knowledge and research, it is easy to determine if a treatment (more specifically a device) is actually FDA approved or just cleared. For this blog, we will focus on the difference between our FDA approved Focused Shock Wave device, the Dornier Epos Ultra, and the FDA cleared Extracorporeal Pulse Activation Technology (EPAT) device, the most common Radial Shock Wave device.

First, lets start with the FDA. All medical device manufactures that want to market their device in the United States must first either go through the 510(k) processed to be “cleared” or the Premarket Approval process to be “approved.” From the FDA website:

https://www.fda.gov/medicaldevices/resourcesforyou/consumers/default.htm#What_is_the_difference_between_Cleared_and_Approved_

Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to (similar) another legally marketed device. A premarket notification submission is referred to as a 510(k) and must be submitted to FDA to review and provide clearance.

Approved medical devices: Approved medical devices are those devices that the FDA has approved a premarket approval (PMA) application or a Humanitarian Device Exemption (HDE) application. This review and approval process is for Class III medical devices (the ones with the highest risk) and involves a more rigorous review than the 510(k) review process.

Sonx Shock Wave’s Dornier Epos Ultra system is an FDA approved, Class III, medical device. It has gone through the stringent, arduous, multi-year process we all think about when we hear FDA approved. FDA approval means the device has been proven to be both safe and effective. Class III is the highest class of device and includes items such as pacemakers, implants, etc; with only 9% of all devices having this classification. Because of this, our treatment must be supervised by a licensed doctor.

EPAT and other radial shock wave devices, are FDA cleared Class I devices registered as Electric Therapeutic Massagers. They have gone through the short 501(k) process, demonstrating they are substantially similar to other approved devices. Class I devices include items such as enema kits and elastics bandages (this is directly from the FDA website). While many licensed doctors use EPAT devices, they can also be used without the supervision of a doctor by physical therapists, chiropractors, athletic trainers, etc.

Now, just to be clear, EPAT is a legitimate device that can be effective for treating several mild and/or acute injuries, but it is not FDA approved and not the same class of device as the Dornier Epos Ultra. Keep in mind, FDA approval is not the only thing to consider when discussing treatment options with your doctor, but it is significant and it reduces the risk of paying for or wasting your time with a treatment that may not work. The best way to know if a device is FDA approved is to look it up on the FDA website as all approvals are available to the public. You can also look at the manufacturer’s website to see if they use the term “approved” or “cleared.” Manufacturers are legally required to use the correct term and face stiff penalties if caught misrepresenting their product. If you are not sure or have questions, you can just give us a call.

Your health is important and we want to make sure you have all the information to make the best decision for your specific chronic injury. If you’d like to learn more about Focused Shock Wave and how Sonx can perform the one 30-minute treatment in the comfort of your doctor’s office, just give us a call. Our network of providers is growing across Texas.

Why Focused Shock Wave Therapy?
Natural Healing
Non-Invasive
FDA Approved
Immediate Pain Relief
No Downtime
Out Patient Procedure
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Patients, ready for pain relief?