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We have developed a wearable technology submitted for FDA approval for the treatment of Major Depressive Disorder 


Depression (MDD) is at scale

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Building On Our Momentum

Our Version 1.0

Marketed under temporary FDA-Clearance to treat depression, anxiety and insomnia. We recently submitted the results of our pivotal depression trial to obtain FDA approval.


Version 1.0 Units Sold



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"Easy to use, affordable, and helped me sleep better. Wife says I’m easier to get along with now."

- Mike, Real Patient

*Individual Results May Vary

"Gone is the everpresent debilitating anxiety that was preventing me from enjoying life."

- Gail, Real Patient

*Individual Results May Vary

"I turned to the Fisher Wallace Stimulator after exhausting every antidepressant I could be prescribed…I would recommend it to anyone suffering from severe depression."

- Camille, Real Patient

*Individual Results May Vary

Community Updates

Our Pivotal Depression Trial for FDA Approval

Submitted to the FDA on December 9th, 2022

Triple-blind, randomized, controlled trial of 255 subjects with moderate to severe Major Depressive Disorder at baseline.

  • SAFE

Conclusion: Potential benefit significantly outweighs potential risk. Our technology is validated as a fast acting, highly effective, safe, self-administered treatment for MDD.

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The combination of novel FDA approval and world-class Version 2.0 industrial design intended to deliver smartphone-level ubiquity


Introducing OAK. The Next Generation Mass Market Wearable for the Treatment of MDD.


Engineering Completion in Q3 2023


You Can Wear


You Can Feel

Freedom, Unboxed

Evidence-based treatment in a choice of seven colors

Rewiring the Standard of Care for Mental Health

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OAK, Connected

Track symptoms, cognitive performance, and engage in talk therapy via secure web app with SMS driven engagement

Longitudinal data and new indication signals

Zero cost of marketing to onboard hardware customers

We are preparing to build and test a first iteration app with current customers by Q4 2023

  • Symptom Tracker 
  • Cognitive Performance
  • Talk Therapy
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Depression is only the beginning

We intend to launch two new pivotal trials in 2023 to obtain FDA indications in 2024 for Generalized Anxiety Disorder and Sleep Maintenance Insomnia

  • Our prior research indicates similar rapidity and responder rate to MDD treatment
  • Our research partners are ready to launch the trials (use of funds)
  • Depression, anxiety and insomnia affect more than half of the US population
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Kelly Roman


Kelly has led Fisher Wallace since 2009. An expert in medical device product development, regulatory affairs, marketing and clinical trial strategy with previous experience in the media and SaaS industries.

With your help we will rewire the standard of care

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Obtain a Free Device with a $1500+ Investment

Receive the OAK device when it's released as a perk for a $1500+ investment. Investing in Fisher Wallace Labs throughStartEngine, one of the leading SEC-regulated equity crowdfunding platforms, is easy. First, create an investment account at after clicking the Invest Now button on the page. Choose the amount you wish to invest, and your payment method.


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