Fisher Wallace

Overview

Fisher Wallace Laboratories, Inc. develops and markets the Fisher Wallace Stimulator, a cranial electrotherapy stimulation (CES) device cleared by the FDA for treating anxiety, depression, and insomnia.¹⁴ The company positions itself in the wearable medical device market, focusing on non-pharmaceutical options for mental health and sleep issues, with over 100,000 customers reported.⁵ It has pursued equity crowdfunding and clinical trials to support its products amid regulatory scrutiny.³

History

Founded in 2007 by Charles Avery Fisher and Martin Wallace, the company acquired its lead CES product from Saul and Bernard Liss in 2006, which already held FDA 510(k) clearance.¹ Renamed the Fisher Wallace Stimulator®, it received Health Canada approval in 2014 but faced an enforcement letter for marketing claims that year.¹ In recent years, it raised over $2 million via StartEngine for clinical trials submitted to the FDA and offers public shares through SEC-regulated crowdfunding.³

Product Lines

Manufacturing

Operates as a manufacturing company for wearable medical devices, with facilities in Brooklyn, New York.²⁴⁵ No details specify in-house versus outsourced production.

Notable Products

• Fisher Wallace Stimulator® - CES device delivering microcurrents via electrodes to treat anxiety, depression, and insomnia.
• Stimulator® Plus - Updated CES model with enhanced features for mental health treatment.
• Electrode Replacement Kit - Disposable sponges and clips for Stimulator use.

Reputation

Perceived as an accessible non-drug option by users for sleep and mood issues, with BBB accreditation since 2014.⁴ Professionals note FDA clearance but cite Cochrane reviews finding insufficient evidence for CES efficacy in depression.¹ Company faced Health Canada warnings on marketing claims and FDA regulatory disputes.¹