Wearable Therapy® FDA Indications for Use:

The AxioBionics Wearable Therapyy® garments with cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient’s skin via electroconductive media gel.

Examples of electrical stimulation applications of the garment are:

     a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief

     b) Neuromuscular Electrical Stimulation (NMES) for:

  • Relaxation of muscle spasms
  • Prevention or retardation of disuse atrophy
  • Increasing local blood circulation
  • Muscle re-education
  • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
  • Maintaining or increasing range of motion

     c) Functional Electrical Stimulation (FES)

Please Note: The information contained or attached herein may concern one or more uses that have not been approved or cleared by the Food and Drug Administration (FDA).

FDA recognizes that off-label uses of medical devices can be an aid in advancing medical discovery and may even be considered the state-of-the-art treatment or as standard of care.

Scientific References

"Muscle atrophy is prevented in patients with acute spinal cord injury using functional electrical stimulation."  View

Spinal Cord, 1998, 36(7): 463-494

Baldi, J., et al.

"Effectiveness of Functional Electrical Stimulation in Improving Clinical Outcomes in the Upper Arm Following Stroke: A Systematic Review and Meta-analysis." View

BioMed Research International, 2015, 1-14 

Amir K. Vafadar, Julie N. Côté, Philippe S. Archambault 

"Functional Electrical Stimulation Enhancement of Upper Extremity Functional Recovery During Stroke Rehabilitation: A Pilot Study" View

Neurorehabilitation and Neural Repair Online, March 16, 2007, 1-9

Gad Alon, Alan F. Levitt, Patricia A. McCarthy 

"Neuromuscular Electrical Stimulation of Completely Paralyzed Abdominal Muscles in Spinal Cord-injured Patients: A Pilot Study" View

Spinal Cord, 46, 2008, 445–450

R. Hascakova-Bartova, J-F. Dinant, A. Parent, M. Ventura

"Alterations in Body Composition and Spasticity Following Subtetanic Neuromuscular Electrical Stimulation Training in Spinal Cord Injury" View

JRRD, Volume 50, Number 2, 2013, 193–202

Amanda Carty, Kirsty McCormack, Garret F. Coughlan, Louis Crowe, Brian Caulfield

"Histochemical Changes in Muscle of Individuals with Spinal Cord Injury Following Functional Electrical Stimulated Exercise Training" View

Spinal Cord, 37, 1999, 264-268

P.D. Chilibeck, J. Jeon, C. Weiss, G. Bell, R. Burnham 

"The Effects of Functional Electrical Stimulation on Shoulder Subluxation, Arm Function Recovery, and Shoulder Pain in Hemiplegic Stroke Patients" View

Arch Phys Med Rehabil, Volume 75, January, 1994, 73-79 

Pouran D. Faghri, Mary M. Rodgers, Roger M. Glaser, John G. Bors, Charles Ho, Pani Akuthota

"Effects of Spinal Cord Injury on Body Composition and Metabolic Profile – Part I" View

The Journal of Spinal Cord Medicine, Volume 37, Number 6, January, 1994, 73-79

Ashraf S. Gorgey, David R. Dolbow, James D. Dolbow, Refka K. Khalil, Camilo Castillo, David R. Gater 

"Skeletal Muscle Hypertrophy and Decreased Intramuscular Fat After Unilateral Resistance Training in Spinal Cord Injury: Case Report" View

The Journal of Spinal Cord Medicine, Volume 33, Number 1, February, 2010, 90-95

Ashraf S. Gorgey, Collin Shepherd

"Neuromuscular Electrical Stimulation Versus Volitional Isometric Strength Training in Children With Spastic Diplegic Cerebral Palsy: A Preliminary Study" View

Neurorehabilitation and Neural Repair, 21, 6, 2007, 475-485

Scott K. Stackhouse, Stuart A. Binder-Macleod, Carrie A. Stackhouse, James J. McCarthy, Laura A. Prosser, Samuel C. K. Lee 

"Effects of Electrical Stimulation in Spastic Muscles After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials" View

Stroke, 46, 2015, 2197-2205

Cinara Stein, Carolina Gassen Fritsch, Caroline Robinson, Graciele Sbruzzi, Rodrigo Della Méa Plentz

"Effectiveness of Functional Electrical Stimulation in Improving Clinical Outcomes in the Upper Arm following Stroke: A Systematic Review and Meta-Analysis" View

BioMed Research International, Volume 2015, 1-14 

Amir K. Vafadar, Julie N. Côté, Philippe S. Archambault

"Long-term Effectiveness of Neuromuscular Electrical Stimulation for Promoting Motor Recovery of the Upper Extremity After Stroke" View

Journal of Rehabilitation Medicine, 43, 2011, 506-510 

Ziling Lin, Tiebin Yan

"Haemodynamic Performance of Neuromuscular Electrical Stimulation (NMES) During Recovery from Total Hip Arthroplasty" View

Journal of Orthopaedic Surgery and Research, 8, 3, 2013, 1-8

Barry J. Broderick, Oisin Breathnach, Finbarr Condon, Eric Masterson, Gearóid ÓLaighin

"Using the Hephaistos Orthotic Device to Study Countermeasure Effectiveness of Neuromuscular Electrical Stimulation and Dietary Lupin Protein Supplementation, a Randomized Controlled Trial." View

PLOS ONE | DOI:10.1371/journal.pone.0171562 February 16, 2017, 1–13

Jochen Zange, Kathrin Schopen, Kirsten Albracht, Darius A. Gerlach, Petra FringsMeuthen, Nicola A. Maffiuletti, Wilhelm Bloch, Jorn Rittweger

We can help you start to live your life again: