Wearable Therapy FDA Indications for Use:

The AxioBionics Wearable Therapy 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

"A Longitudinal Retrospective Study of a Wearable Neuromuscular Electrical Stimulation (NMES) System Shows Significant Improvement of Arm Usage in Hemiparetic and Hemiplegic Patients"

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View Preprint of Research Square

Philip Muccio, Rafik Salama, Nipun Chopra, Josh Scheuller, David Durrant, and Edward Dabrowski

"Femoral Artery Blood Flow and Microcirculatory Perfusion During Acute, Low-Level Functional Electrical Stimulation in Spinal Cord Injury" View

Thomas J. Barton, David A. Low, Thomas W.J. Janssen, Maurits Sloots, Christof A.J. Smit, Dick H.J. Thijssen

"Difficulty With Evacuation After Spinal Cord Injury: Colonic Motility During Sleep and Effects of Abdominal Wall Stimulation" View

Mark A. Korsten, Noel R. Fajardo, Alan S. Rosman, Graham H. Creasey, Ann M. Spungen, William A. Bauman

"Therapeutic Effectiveness of AxioBionics Wearable Therapy Pain Management System in Patients with Chronic Low Back Pain" View

Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders, 2021, Volume 14:1-11

Philip Muccio, Josh Schueller, Miriam van Emde Boas, Norm Howe, Edward Dabrowski, David Durrant

"Exploring Neuromuscular Electrical Stimulation Intensity Effects on Multifidus Muscle Activity in Adults With Chronic Low Back Pain: An Ultrasound Imaging–Informed Investigation" View

Clinical Medicine Insights: Arthritis and Musculoskeletal Disorders, 2019, Volume 12: 1–9

Jaclyn Megan Sions, DeJ’a Chyanna Crippen, Gregory Evan Hicks, Abdulmohsen Meshari Alroumi, Tara Jo Manal and Ryan Todd Pohlig

"Neuromuscular Electrical Stimulation Training Results in Enhanced Activation of Spinal Stabilizing Muscles During Spinal Loading and Improvements in Pain Ratings" View

33rd Annual International Conference of the IEEE EMBS, 2011

Simon Coghlan, Louis Crowe, Ulrik McCarthyPersson, Conor Minogue, and Brian Caulfield

"Effectiveness of lumbar orthoses in low back pain: Review of the literature and our results" View

Orthopedic Reviews 2018, 10:7791, 141-146

Cordelia Schott, Sonja Zirke, Jillian Marie Schmelzle, Christel Kaiser, Lluis Aguilar i Fernández

"Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain" View

JAMA, 2018 Mar 6; 319(9): 872–882

Erin E. Krebs, Amy Gravely, Sean Nugent, Agnes C. Jensen, Beth DeRonne, Elizabeth S. Goldsmith, Kurt Kroenke, Matthew J. Bair, Siamak Noorbaloochi

"Direct and Indirect Benefits Reported by Users of Transcutaneous Electrical Nerve Stimulation for Chronic Musculoskeletal Pain: Qualitative Exploration Using Patient Interviews" View

Physical Therapy, Volume 95, Number 11, November 2015, 1518–1527

Peter William Gladwell, Kathryn Badlan, Fiona Cramp, Shea Palmer

"Using TENS for pain control: the state of the evidence" View

Pain Management (2014) 4(3), 197-209 

Carol GT Vance, Dana L Dailey, Barbara A Rakel, Kathleen A Sluka

"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

"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 

"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

"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

"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

"Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review." View

Journal of Pediatric Rehabilitation Medicine: An Interdisciplinary Approach 9 (2016) 83–99

Glendaliz Bosques, Rebecca Martin, Leah McGee, Cristina Sadowsky

"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 

"Rehabilitation with Neuromuscular Electrical Stimulation Leads to Functional Gains in Ambulation in Patients with Secondary Progressive and Primary Progressive Multiple Sclerosis: A Case Series Report" View

The Journal of Alternative and Complementary Medicine 16(12), 2010, 1343-1349 

Terry L. Wahls, David Reese, Daniel Kaplan, Warren G. Darling

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

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

James C Baldi, RD Jackson, Rich Moraille, W Jerry Mysiw

"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 lumbosacral orthoses on spine stability: What changes in EMG can be expected?" View

Journal of Orthopaedic Research 22, 2004, 1150-1155 

Jacek Cholewicki

"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

"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

"Electrical calf muscle stimulation in patients with post-thrombotic syndrome and residual venous obstruction after anticoagulation therapy" View

International Angiology 2018 October;37(5):400-10 DOI: 10.23736/S0392-9590.18.03997-4

Kirill Lobastov, Vladimir Ryzhkin, Athena Vorontsova, Ilya Schastlivtsev, Victor Barinov, Leonid Laberko, Grigory Rodoman

"Neuromuscular electrical stimulation for the prevention of venous thromboembolism (Review)" View

Cochrane Database of Systematic Reviews 2017, Issue 11. Art. No.: CD011764.
DOI: 10.1002/14651858.CD011764.pub2.

Hajibandeh S, Hajibandeh S, Antoniou GA, Scurr JRH, Torella F

"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

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