PEMF devices according to the FDA in the USA
In the USA, NONE of the PEMF devices, including the Curatron have been, cleared, approved or certified for use for general purpose health applications by the FDA. Some devices are listed or registered as massage or biofeedback devices but NONE, including the Curatron are approved for general purpose health or pain relief.
Some companies use words to make the reader believe that their device has been FDA approved and some of companies have bold face statements on their website(s). We recommend you read the following in its entirety to learn more about FDA regulation.
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Classification
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Clearance 510(k)
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Approval [PMA or Premarket Approval]
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Listing
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GMP [Good Manufacturing Practice]
Classification of Medical Devices in the USA by the FDA
The FDA categorizes medical devices into one of three classes: Class I, II, or III based on risks and regulatory controls, to provide the safety and effectiveness. Class I devices generally pose the lowest risk and Class III devices pose the highest risk.
Class I are for low risk devices and are therefore subject to the least regulatory controls. For example, dental floss is classified as a Class I medical device.
Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II medical devices.
Class III devices are the highest risk [life threatening] devices and are subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are allowed to be marketed. For example, replacement heart valves are classified as Class III devices.
Clearance for Medical Devices by the FDA
Before a medical device can be marketed in the USA a marketing application must be submitted to the FDA and clearance obtained.
Most Class I devices and some Class II devices are exempt from the requirement for submission of a marketing application. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled.
Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance in order to demonstrate that the device is safe and effective and substantially equivalent to a legally marketed device for which no premarket approval (PMA) is required.
510(k) Exempt medical devices: Medical devices that do not require FDA review before the devices are marketed are considered "510(k) exempt." These medical devices are mostly low-risk, Class I devices and some Class II devices that do not to require a 510(k) to provide a reasonable assurance of safety and effectiveness. They are not exempt from certain general controls, like suitable for intended use, properly labeled and manufactured under a quality system.
Curatronic also manufactures Biomove stroke rehabilitation devices cleared by the FDA in the USA for marketing.
Click on these PDF’s to see these clearance documents.
Biomove 5000 FDA clerance
Biomove 3000 FDA clerance
Approval of Medical Devices in the USA
Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A premarket approval application is submitted to FDA to request clearance to market, or to continue marketing of a Class III medical device.
Approved medical devices are those devices for which FDA has approved a PMA application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a much more rigorous premarket review than the 510(k) pathway.
For use of PEMF technology this PMA approval process is required, which may take around 5 years and will possibly cost millions of dollars, without the knowledge if by the end of this process, the device will be approved by the FDA or not. Even in case such an approval will be obtained the application is usually limited only to one application. No manufacturer of PEMF devices in his right mind will go through this unsure and super expensive process.
Good Manufacturing Practice for Medical Devices
Good Manufacturing Practice are the requirements set forth in the Quality System (QS) regulation and require that manufacturers have a quality system for the design, manufacture, packaging, labeling, storage and servicing of medical devices intended for distribution in the USA and the rest of the world.
Listing / Registration of Medical Devices by the FDA in the USA
A medical device is FDA listed if the company manufactuing or distributing a medical device has online listed the device on the FDA website. This listing is an administrative registration procedure and does neither require clearance nor approval for the device. This is a self-declaration by the manufacturer and Curatronic has done this as well, see here under.
Approval of Medical Devices in Europe
The Curatron PEMF devices are approved by health authorities for medical therapy for human applications in Europe and certified as medical devices according to the Medical Device Directive 93/42/EEC. The devices are manufactured according to ISO 13485 for Good Manufacturing Practice. Our certificates can be seen on THIS PAGE.