PEMF NOW FDA Clearance

FDA Clearance & Regulatory Oversight of PEMF NOW

PEMF NOW has been reviewed and cleared by the FDA as being safe and effective when used as directed. This clearance involved the FDA’s thorough examination of safety and performance data from clinical trials, device design documents, internal testing reports, and manufacturing processes, along with extensive external (independent) testing. Additionally, the quality system and facilities undergo regular audits by the FDA to ensure ongoing compliance. PEMF NOW is classified as ‘Class II with Special Controls’ (previously Class III), receiving clearance through the Premarket Notification [510(k)] Program.

Here’s some examples of common Class II medical devices:

Guide to Recognizing FDA-Compliant PEMF Devices

Getting clearance for a PEMF device with Class II Special Controls is a challenging, expensive, and time-consuming process. Most companies attempt to skirt this rigorous FDA process while attempting to convince consumers and medical professionals that they provide legitimate PEMF devices. The best way to spot these devices is to review the instruction manual for the indications for use reviewed by the FDA. Specific language on websites can also be used to identify these devices. To distinguish authentic devices from deceptive ones, watch for these key phrases and tactics:

1.

Be cautious of products that do not claim to be medical devices, accompanied by statements such as, “_______ has not been evaluated by the FDA and is considered a general wellness device. These products do not claim to diagnose, treat, cure, or prevent any medical condition.”

It’s important to note that the FDA categorizes a medical device as a product intended for use in the diagnosis, treatment, or prevention of disease.

2.

Be wary when the only claim made is that “PEMF therapy has been an FDA-approved therapy for many years.” This is misleading since the FDA does not grant blanket approvals for therapies or technologies.

3.

Some may assert their FDA registration or that of their product. However, it’s essential to understand that all medical device manufacturers and devices must register with the FDA. Frequently, these entities might “self-classify” their devices as massagers, braces, etc., which fall into the Class I exempt category, meaning these products do not undergo FDA evaluation.

4.

There are instances where a device is claimed to be FDA Cleared but cleverly uses the Class II muscle stimulator code to bypass the Class II Special Controls. These devices are typically meant for muscle conditioning, not pain relief.

The truthfulness of such claims can be found by examining the indications for use in the instruction manual, determining whether the FDA has indeed cleared the device for pain relief. Additionally, the FDA’s database can be searched using their product code to verify claims.