HARMONIC BIONICS ANNOUNCES COMMERCIAL LAUNCH OF THE HARMONY SHR™ ROBOTIC REHABILITATION SYSTEM FOLLOWING FDA REGISTRATION

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AUSTIN, Texas, April 18, 2023 /PRNewswire/ -- Rehabilitation robotics company Harmonic Bionics announced today that the company has registered their flagship exoskeleton Harmony SHR™ with the FDA as a Class II 510(k)-exempt device.

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Retrieved on: 
Tuesday, April 18, 2023
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Tags: 
Wearable, Stroke, Bionics, Mechanical engineering, AOTA, Rehabilitation, American Occupational Therapy Association, Ascending limb of loop of Henle, Assistant, Harmony, Auburn University, Occupational therapy, Patient, DSM-IV codes, Neuroplasticity, SHR, Robotics, FDA, Conference, Medical device, Nursing
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TEXAS, MO
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HARMONIC BIONICS, HARMONIC BIONICS, INC.
Summary
Key Points: 
  • AUSTIN, Texas, April 18, 2023 /PRNewswire/ -- Rehabilitation robotics company Harmonic Bionics announced today that the company has registered their flagship exoskeleton Harmony SHR™ with the FDA as a Class II 510(k)-exempt device.
  • The Harmony SHR Robotic Rehabilitation System works with a patient's scapulohumeral rhythm (SHR) to enable natural, comprehensive therapy for both arms.
  • Harmonic Bionics will be demonstrating the Harmony SHR system later this week in booth 126 at AOTA Inspire, the largest occupational therapy conference in the country.
  • For more information on Harmonic Bionics and Harmony SHR, please visit www.harmonicbionics.com .


HARMONIC BIONICS ANNOUNCES COMMERCIAL LAUNCH OF THE HARMONY SHR™ ROBOTIC REHABILITATION SYSTEM FOLLOWING FDA REGISTRATION

AUSTIN, Texas, April 18, 2023 /PRNewswire/ -- Rehabilitation robotics company Harmonic Bionics announced today that the company has registered their flagship exoskeleton Harmony SHR™ with the FDA as a Class II 510(k)-exempt device. The company will be exhibiting the Harmony SHR system at the American Occupational Therapy Association (AOTA) Inspire 2023 Annual Conference taking place this week in Kansas City, MO.

The Harmony SHR Robotic Rehabilitation System works with a patient's scapulohumeral rhythm (SHR) to enable natural, comprehensive therapy for both arms. As an upper extremity exercise device, Harmony may assist in the treatment of upper body movement impairments including neurological injury (such as stroke), neuromuscular disease/disorder, musculoskeletal disease, post-procedure musculoskeletal rehabilitation, and upper limb prosthetic or transplant rehabilitation.

"Our team has worked so hard to reach this milestone, but we are especially grateful to the therapists and clinicians we have worked with to ensure our Harmony SHR system is an effective tool for providers and their patients," said Harmonic Bionics CEO Christopher Prentice. "In addition to assisting in recovery, we know rehab robotics and technology is one way to address workforce challenges that are plaguing the healthcare industry and we believe Harmony can be a part of that solution."

Harmonic Bionics will be demonstrating the Harmony SHR system later this week in booth 126 at AOTA Inspire, the largest occupational therapy conference in the country. The company will also host a special seminar entitled "What is Bilateral Sync Therapy? Using Advanced Technology to Promote Neuroplasticity" presented by Harmonic Bionics' Clinical Education & Training Specialist on Friday, April 21 at 1:00 pm in Hall C, Theatre 2. Attendees will receive .75 contact hour (.75 NBCOT PDU).

Last month, Harmonic Bionics fulfilled a purchase order for Auburn University and installed a Harmony SHR system at the Wearable and Bio-Robotics Laboratory (WeBR Lab) led by Dr. Chad Rose, Assistant Professor of Mechanical Engineering. For more information on Harmonic Bionics and Harmony SHR, please visit www.harmonicbionics.com.

About Harmonic Bionics, Inc.

Harmonic Bionics, led by a highly talented and successful leadership team with vast medical device experience, is a commercial-stage robotics and digital health company that aims to unlock human functional capabilities through robotics. Our flagship product, Harmony SHR™, is a bilateral upper extremity exoskeleton that works with a patient's scapulohumeral rhythm (SHR) to enable natural, comprehensive arm and shoulder therapy for those living with neurological and musculoskeletal movement impairments.

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SOURCE Harmonic Bionics

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