21 CFR 876.5984 — Cranial Electrotherapy Stimulator For Weight Management

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5984

Identification

Modius Lean is a non-invasive, home-use neurostimulation medical device intended to support weight management alongside diet and exercise, in adults aged 22 years and older, who have a Body Mass Index of 27kg/m2 and greater. It is a battery-powered device that applies electrical current to a patient's head through electrodes placed on the skin.

Classification Rationale

FDA has determined that the device can be classified in Class I. FDA believes that class I (general) controls provide reasonable assurance of the safety and effectiveness of the device type.

Product Codes