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Flow Neuroscience AB · Model FL-100-A-US-PADS-48 · UDI-DI 17314581000107

JXK Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 and older who are not considered treatment refractory to medication. For prescription use only (Rx only). Kit comprising of: FL-100 (US version) UDI: 07314581000001 Two boxes each with 24 single-use, non-sterile electrode pads. UDI: 17314585010003 Kit for first prescription to a patient.

Recalls

Date	Firm	Reason
2007-10-29	Neuro-Fitness LLC	No FDA clearance for the .35Hz/.45Hz frequency option on device.
2007-07-19	Health Directions, Inc	Peak voltage test result not in acceptable limits.
2004-04-08	Health Directions, Inc	Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.