FDA PEMF Product Code: What the New SGT Code Means for OTC Devices
The FDA PEMF product code landscape just changed. Working with Borderless MedDev, the FDA has created a new product code, SGT, for over-the-counter pulsed electromagnetic field (PEMF) devices. The Aura Wave by AuraWell is the first product cleared under it.
How PEMF Devices Have Been Regulated
PEMF therapy devices have existed since the 1970s as prescription-only therapy devices. The pulsing magnetic field can induce a low-level current in tissue, which increases circulation and reduces muscle soreness from exercise.
In 2017, the first over-the-counter PEMF device was cleared, making the technology available to the general public for healthy muscle tissue and improved performance. That clearance, and every OTC PEMF clearance since, fell under product code NGX, which was designated for transcutaneous electrical nerve stimulation (TENS) devices.
The New SGT Product Code
With the clearance of the Aura Wave PEMF system by AuraWell, the FDA created product code SGT. The agency defines it this way: a device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices used in physical medicine and rehabilitation, it is not intended for patients with medical conditions.
The FDA also describes how these devices work in a way that separates PEMF from TENS. The device uses a magnetic coil to produce a time-varying magnetic field, which induces a secondary electric field in the targeted tissues. That field non-invasively and temporarily increases local blood flow and stimulates healthy muscles.
| NGX (TENS product code) | SGT (new PEMF product code) | |
|---|---|---|
| Technology the code is built around | Transcutaneous electrical nerve stimulation (TENS) | A magnetic coil produces a time-varying magnetic field that induces a secondary electric field in tissue |
| Intended use | Electrical stimulation devices | Used for other than medical purposes, to temporarily increase local blood flow and stimulate healthy muscles |
| Intended patients | Not defined around PEMF | Not intended for patients with medical conditions |
| Regulatory path for OTC PEMF | OTC PEMF devices were cleared here after 2017, while some low-power PEMF devices were sold as Class 1 under a massager code | Class 2, with 510(k) clearance required. The Class 1 massager route is no longer an option |
| Fit with the consensus standard | IEC 60601-2-10 only tangentially applies to PEMF | Code defines PEMF as separate from TENS |
| Example devices | Nova HD+ (K220938), which may move to SGT | Aura Wave by AuraWell (K250896), the first device cleared |
What SGT Means for Class and Pathway
By creating this product code, the FDA makes clear that all PEMF devices intended to be sold over the counter are regulated as Class 2 medical devices. They require 510(k) clearance to be legally sold in the United States.
That ends an old shortcut. Some low-power PEMF devices had been sold as Class 1 devices under a product code typically used for massagers. That regulatory pathway is no longer an option. If you are planning a PEMF device, our FDA Submission Preparation and Filing team can help you build a 510(k) that fits the new code.
Why NGX Was a Poor Fit for PEMF
During the Aura Wave review, Borderless MedDev provided ample evidence that the device was safe, effective, and substantially equivalent to its predicate. We also pointed out that product code NGX presents challenges for PEMF devices. For example, IEC 60601-2-10, the recognized consensus standard the FDA cites for products under that code, only tangentially applies to PEMF.
Aura Wave: The First Device Cleared Under SGT
The Aura Wave is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles and other tissues. It is unique as the only cleared OTC PEMF device with five applicator accessories, or coils, that provide selective therapy throughout the body. You can read the full FDA 510(k) summary for the Aura Wave (K250896).
Today the Aura Wave is the only device in the SGT category. The FDA told Borderless MedDev that similar devices previously cleared under NGX may be moved to the new code. One example is the AuraWell Nova HD+ (K220938).
Working With the FDA on New Technology
Borderless MedDev has a long track record working with the agency and advancing innovative medical technologies. Our Chief Regulatory Officer, Brodie Pedersen, is also Vice Chair of IEC 62A, the committee developing the 4th edition of the medical device safety standard IEC 60601-1. In that role he works with regulators, including the US FDA, so the new edition is recognized and safeguards medical electrical equipment, systems, and software worldwide. Meet the Borderless MedDev team.
If you are developing a PEMF device, or you hold a clearance that may be affected by the new code, talk to us. If you have received a deficiency letter, our FDA Clearance Remediation team can help.