ManaFlexx 2 was previously indicated for Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS), as a prescription device, which is now available as an over-the-counter (OTC) device
ManaMed gets expanded FDA approval for ManaFlexx 2. (Credit: PRNewswire/ManaMed)
US-based medical equipment maker ManaMed has received the US Food and Drug Administration (FDA) expanded approval for its ManaFlexx 2 electrical stimulation (EMS) device.
ManaFlexx 2 is a compact medical device designed to deliver electrical pulses to the user’s skin using the company’s patented wireless technology.
The device was previously indicated for Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS), as a prescription device.
With the expanded approval, ManaFlexx 2 is now available as an over-the-counter (OTC) device, for both NMES and TENS indications, without needing any prescription.
ManaMed president and CEO Trevor Theriot said: “Our goal was to make both NMES and TENS simple and practical for professionals and non-professionals alike.
“Now with the over-the-counter clearance for ManaFlexx 2, we have an ideal solution to increase access for the at-home user who seeks the benefits of NMES for improved muscle performance or TENS for symptomatic relief and management of chronic pain, intractable pain and relief of pain associated with arthritis.”
ManaMed has designed ManaFlexx 2 as a completely portable and wireless device, that may be placed anywhere treatment is desired, and is reusable and rechargeable.
The company said that professional and everyday athletes have been using Neuromuscular Electrical Muscle Stimulation (NMES) for years.
NMES stimulates healthy muscles to improve muscle and facilitate muscle performance and temporarily enhances blood circulation in the healthy muscles of the lower extremities.
Transcutaneous Electrical Nerve Stimulation (TENS) provides temporary relief of pain related to sore and aching muscles in the shoulder, waist, arm and leg due to strain from exercise or work.
The FDA approval expands the previous indication as the non-invasive device for the management of post-surgical and post-traumatic acute pain, said the US medical device maker.
Last year, ManaMed received US FDA approval for its ManaSport ultrasound therapy device, to provide pain relief and treatment for soft-tissue injuries for athletes and sports professionals.