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Gravity-Defying Success: FDA Approval Journey of an Innovative Anti-Gravity Treadmill

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Company: AlterG

Industry: Medical and Consumer Products

Use Case: Anti-Gravity Treadmill

Services Used: Analog Electronic Design, Verification Testing

Results:

  • Identified and eliminated source of device malfunction
  • FDA approval as a medical device
  • Streamlined process for device manufacturing

Customer Introduction

AlterG was a startup company designing an anti-gravity treadmill that provides air pressure to lift most of a person's weight off their feet, so they can exercise when injured or they can exercise longer.

Problem/Goal

  • The unit was getting reset by static discharges created by the air blower.

    The circuit seamlessly interfaces to motors and fans running on 220 VAC and delicate sensors measuring force and pressure.
  • The company lacked senior electrical engineering skills.

    Isolate electrical issues to ensure reliable, consistent operation of the unit.
  • The unit must meet medical requirements for electrical isolation, emissions, immunity, safety, and verification testing.

    The anti-gravity treadmill was sold to professional teams and athletes, but the company wanted to expand its usage to appropriate medical and therapeutic applications. It had to be classified as a class II medical device and pass FDA requirements to do so.

Solution

The company chose to partner with Voler Systems to leverage its vast expertise in electronic design and medical devices.

  • Conducted tests to identify the source of the static discharge. The circuit was redesigned with optical isolation and improved shielding and grounding to eliminate the problem.
  • Collaborated with the transformer supplier, sharing design information and creating a custom transformer that not only powered the entire device but also fulfilled the stringent requirements of medical isolation and leakage current.
  • Prepared the design change requirements, ensuring they were ready for verification testing. Each requirement was defined with a clear pass or fail indication. 

Results & Benefits

  • Eliminated the persistent static discharge issue with a single design change resulting in a significant enhancement to the overall performance and reliability of the treadmill.
  • Achieved FDA approval as a medical device, validating its quality, safety, and market acceptance.
  • Established a streamlined process for designing and evaluating the unit, facilitating manufacturing.

Inspiration

Voler Systems' expertise in analog circuit design and deep understanding of the medical device approval process played a pivotal role in driving the project's success and was critical to the project's success.

"Voler Systems consistently went above and beyond, delivering excellence in both their work and customer service. They were an invaluable partner in our journey to success."
 

Contact Voler today to unlock innovation, expertise, and exceptional results for your project.

Contact Voler Systems Today

 
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