MANAMED Receives Expanded 510(k) Clearance for ManaFlexx 2

Novel Device Now Available Without a Prescription

DENTON, Texas, Nov. 16, 2023 /PRNewswire/ -- The US Food and Drug Administration (FDA) has granted over-the-counter marketing clearance for the ManaFlexx 2^®, an Electrical Stimulation (EMS) device, from MANAMED^®, LLC. ManaFlexx 2 is a compact medical device that delivers electrical pulses to the user's skin through the company's patented wireless technology for two distinct uses. The expanded indication applies to both ManaFlexx 2 device's indications: Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS).

Unlike conventional EMS systems, ManaFlexx 2 was designed for ease of use; it is a completely portable and wireless device, that may be placed anywhere treatment is desired, it is reusable and rechargeable. The ManaFlexx 2 was originally only available by prescription through a healthcare provider.

Professional and everyday athletes have been appreciating the many benefits of Neuromuscular Electrical Muscle Stimulation (NMES) for years. Electrostimulation therapy isn't new technology ? NMES has been used to stimulate healthy muscles in order to improve muscle and facilitate muscle performance. It also intended to temporarily increase blood circulation in the healthy muscles of lower extremities. Now weekend warriors and consumers will have increased access to NMES technology.

Transcutaneous Electrical Nerve Stimulation (TENS), is a separate function of ManaFlexx2. The TENS function provides temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm and leg due to strain from exercise or normal household and work activities . This expanded indication joins the previous FDA clearance granted for the noninvasive device as an adjunctive treatment in the management of post-surgical and post- traumatic acute pain.

"Our goal was to make both NMES and TENS simple and practical for professionals and non-professionals alike", explained MANAMED President and CEO, Trevor Theriot. "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."

ABOUT MANAMED, LLC

ManaMed designs, develops and distributes orthopedic solutions that keep active, high-performing people in the game and back-on-track following injury or surgery. Our extensive catalog spans vascular and electrotherapies, assisted mobility, electrical stimulation, and DVT prevention products. We partner with orthopedists, physical therapists, surgeons, and DME companies across the US to keep patients of all ages and backgrounds healthy and comfortable while on the path to recovery. We welcome opportunities to work together to solve tough challenges with innovative solutions. For more information, visit manamed.com, or talk to one of us by emailing [email protected] or calling 888.508.0712.

Media Contact:
Stephanie Green
[email protected]
940-331-6782

SOURCE ManaMed LLC