VibeTech Inc.: VibeTech One receives FDA registration

Offers Range of Treatment Modalities to Restore Muscle Strength and Function to Mobility-impaired

VibeTech, Inc. has completed U.S. FDA (Food and Drug Administration) registration and listing for the VibeTech One, its premier high-tech rehabilitation product. VibeTech is dedicated to setting industry standards to ensure that the most effective, efficient treatments are afforded to patients who currently have no comprehensive solution to disuse atrophy and functional decline.

The intended uses of the VibeTech One are to restore strength and function to mobility-impaired patients and others with a deficit in weight-bearing physical activity. Treatment modalities include neuromuscular reeducation, therapeutic exercises, therapeutic activities, gait training, manual therapy, and other forms of lower extremity rehabilitation.

“Our registration and listing with the FDA is a critical milestone for VibeTech. It gives us the proper legal and regulatory status to sell our product throughout the U.S. As part of this process, we established the VibeTech One’s classification with the FDA, which enables the product to be marketed for a variety of indications for use (diagnoses) and intended uses (treatment modalities) that are directly relevant to our customers. Our classification permits the VibeTech One to be used by rehabilitation providers to offer a range of treatment modalities their patients need in order to restore strength and function. The form and function of the device are such that these treatments can be provided to any patient, regardless of their physical ability level.”
-Jeff Leismer, PhD, Founder and Chief Technology Officer

Treatment consists of 10-minutes of biomimetic mechanical stimulation, requiring anywhere from 0-100% of the patient’s effort depending on the needs of the patient. Two types of mechanical stimulation are provided to simulate partial weight-bearing physical activity in patients who are too weak or de-conditioned to perform physical activity on their own. These stimuli include adjustable partial bodyweight loading provided to the legs of a semi-recumbent patient, and a stimulus that replicates muscle vibration generated by the strength and postural muscles of the legs and lumbar region. The result is activation of muscle fibers throughout the lower extremities and low back.

About VibeTech
A pioneer in the medical rehabilitation device industry, VibeTech, Inc. improves people’s health, independence and quality of life through vibration science. The company’s cornerstone product, the VibeTech Oneä semi-recumbent vibration therapy system, is the only comprehensive solution to muscle disuse atrophy and functional decline, especially in the most difficult patients to treat—those with mobility impairments. Beyond VibeTech One, no other established treatment modality, including electronic stimulation, continuous passive motion, or ultrasound/diathermy, provides the comprehensive solution to satisfy all market needs.

The foundational vibration technology for the VibeTech One Rehabilitation Chair was initially developed as a countermeasure to disuse atrophy in astronauts whose strength had been compromised due to the negative effect of long duration space flight. This proprietary FDA-registered technology has now been extended for use in hospitals, skilled nursing facilities, physical therapy clinics, sports medicine facilities, and other rehabilitation centers, and offers safe, reliable and reimbursable treatment for an expanded patient base, including severely debilitated patients.

For more information, contact VibeTech sales at 920.395.5339, email sales@vibetechglobal.com, or visit us at www.vibetechglobal.com.