(a) Identification. An EEG-driven upper extremity powered exerciser is a non-invasive prescription device intended for rehabilitation by driving movement or exercise of an impaired upper extremity in response to the detection of purpose oriented electrical activity produced by the patient's brain.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must capture any adverse events observed during clinical use and must demonstrate that the EEG signal can be translated into intended motion.

(2) Software verification, validation, and hazard analysis must be performed.

(3) Performance data must demonstrate the electromagnetic compatibility, electrical safety, battery safety, and wireless compatibility of the device.

(4) The device components that contact the patient must be demonstrated to be biocompatible.

(5) Performance data must validate the reprocessing instructions for the reusable components of the device.

(6) Labeling must include:

(i) Instructions on fitting the device to the patient;

(ii) Information on how the device operates and the typical sensations experienced during treatment; and

(iii) Reprocessing instructions.

[88 FR 983, Jan. 6, 2023]