Favorable Safety Profile
Real-world evidence from over 40,000 users shows a low incidence of adverse reactions1.
Contraindications
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Open wounds, broken skin, or damaged skin at the electrode site.
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Metallic skull reconstruction at the electrode site.
Warnings and Precautions
The device should only be used by people at least 18 years old who are diagnosed with depression (Major Depressive Disorder or MDD) for which they are receiving treatment by a medical provider.
Take extra precaution and discuss with your clinician the following circumstances, if applicable:
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You are pregnant, think you might be, or become pregnant while using the device.
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You currently have thoughts about suicide or harming yourself.
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You have been told there is a problem with your skull or if you have metal parts in or around the brain, like brain surgery clips, metal plates or screws in the skull, cochlear implants or brain pacemakers such as those used for Parkinson’s disease. It is fine to use the device if you have dentures.
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You have been diagnosed with “epilepsy”, “seizure(s)”, “seizure disorder”, unexplained loss or alteration of consciousness, or according to a medical provider you have had symptoms of a possible seizure.
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You have a chronic skin condition affecting your forehead or scalp, such as psoriasis.
There is a risk that the device is ineffective for the individual patient. The device should only be used by patients whose clinical course is supervised by a medical provider.
Special populations
Other chronic conditions: Used by individuals with diabetes, heart disease, hypertension, asthma, co-occurring mental health conditions, neurodivergence, and brain injuries/disorders
Pregnancy: Not licensed for use; research ongoing.
Breastfeeding: No effect on breast milk production observed in existing studies.
Postpartum: Successfully used in perinatal mental health services.
Children and Adolescents: Not licensed for use; studies ongoing for ages 14+
Adverse reactions
Flow FL-100 has shown a favorable safety profile to date, with both clinical trial2 and real-world user data suggesting a low incidence of adverse reactions. Based on real world evidence from >40,000 users, the self-reported incidence rate of side-effects is 4.5%1.
The side effects of the Flow FL-100 reported in clinical studies were generally mild and transient. The main risks of the device are:
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Skin dryness.
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Skin irritation or redness after prolonged use.
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Transient headache.
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Stinging, burning, or itching sensations at the stimulation site.
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Skin burns (typically in cases of electrode pad reuse or use of dried-out electrode pads which is not recommended).
Adverse events should be reported to the FDA MedWatch program. Reports can be submitted online at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by submitting Form FDA 3500. Adverse events should also be reported to Flow Neuroscience at support@flowneuroscience.com.
Support and contact Information
For technical support and assistance, patients can contact support@flowneuroscience.com.
Clinicians can enquire about setup, pricing, and training support by contacting clinical@flowneuroscience.com.
Flow is supported by a randomised controlled trial published in Nature Medicine and is already used in routine clinical care across the UK and EU, with more than 55,000 patients treated in real-world settings to date2.
References: 1. Data on file. Flow Neuroscience Real-world reports. 2025. 2. Woodham, R.D., Selvaraj, S., Lajmi, N. et al. Nat Med (2024).
Please see more information about Flow FL-100, including the FDA-approved labeling, available here.
Indication
Flow FL-100 is intended for the treatment of moderate to severe major depressive disorder (MDD) in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.
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