FDA product code QOL: Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
QOL is the FDA product code for electroencephalography (eeg)-driven upper extremity powered exerciser. It is a Class II device, regulated under 21 CFR 890.5420 and reviewed by the Physical Medicine panel. Devices under QOL reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
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
| Field | Value |
|---|---|
| Device name | Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser |
| Device class | Class II |
| Regulation | 21 CFR 890.5420 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QOL devices
openFDA lists no recalls for product code QOL.
Frequently asked questions
What is FDA product code QOL?
QOL is the FDA product code for electroencephalography (eeg)-driven upper extremity powered exerciser. It is a Class II device, regulated under 21 CFR 890.5420 and reviewed by the Physical Medicine panel.
What device class is QOL?
Class II, regulation 21 CFR 890.5420. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QOL
- Run a recall and safety report across every QOL manufacturer
- Watch product code QOL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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