MANAMED Obtains Expanded 510(k) Clearance for ManaFlexx 2
17 November 2023
The ManaFlexx 2® device, developed by MANAMED®, has obtained marketing clearance for over-the-counter sales from the U.S. Food and Drug Administration (FDA). This clearance allows the direct sale of the device to consumers without requiring a prescription. The ManaFlexx 2® is an Electrical Stimulation (EMS) device that employs patented wireless technology to deliver electrical pulses to the user's skin, serving two distinct purposes: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).
Designed for convenience, the ManaFlexx 2® is compact, portable, and wireless, distinguishing it from conventional EMS systems. It is also reusable and rechargeable. Initially available only through a healthcare provider's prescription, the device has now received expanded indications for both NMES and TENS applications.
The TENS function of the device is highlighted for providing temporary relief from pain associated with sore and aching muscles in various body parts due to strain from exercise or routine daily activities. Furthermore, the ManaFlexx 2® has previously gained FDA clearance as an adjunctive treatment for managing post-surgical and post-traumatic acute pain.
With this over-the-counter marketing clearance, consumers can now purchase and use the ManaFlexx 2® directly, making it more accessible for individuals seeking noninvasive electrical stimulation for pain relief and neuromuscular stimulation.