21 CFR 890.5420 — Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
Neurology (NE) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5420
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QOL | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser | 2 | 1 |
Special Controls
QOL — Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
In combination with the general controls of the FD&C Act, the electroencephalography (EEG)driven powered exerciser is subject to the following special controls:
De Novo Order DEN200046
QOL — Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
*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.
eCFR
QOL — Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
(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.
Ecfr Llm
