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# De Novo Granted for Stroke Rehab Device
- URL: https://www.fdaweb.com/de-novo-granted-for-stroke-rehab-device/
- Published: 2021-04-23T12:00:00.000Z
- Updated: 2026-09-14T16:56:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149176

FDA has granted a de novo marketing authorization for Neurolutions’ IpsiHand Upper Extremity Rehabilitation System for use in adult patients undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The brain-computer-interface device is intended to assist in rehabilitatimg stroke patients with upper extremity disability.

An [FDA release](https://content.govdelivery.com/accounts/USFDA/bulletins/2cfa7cb?ref=fdaweb.com) says post-stroke rehabilitation helps individuals overcome disabilities that result from stroke damage. The IpsiHand uses “non-invasive electroencephalography (EEG) electrodes instead of using an implanted electrode or other invasive feature to record brain activity,” it says. “The EEG data is then wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand. The device aims to help stroke patients improve grasping. The device is prescription-only and may be used as part of rehabilitation therapy.”