Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
The Electroencephalography (EEG)-Driven Upper Extremity Powered Exerciser is a non-invasive prescription neurological rehabilitation device intended to drive movement or exercise of an impaired upper extremity in response to the detection of purpose-oriented electrical brain activity captured by EEG. It is used in rehabilitation settings to support motor recovery. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 890.5420 in the Neurology specialty (reviewed by the Physical Medicine panel). It carries product code QOL and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QOL
- Device Class
- FDA class 2
- Regulation Number
- 890.5420
- Medical Specialty
- Neurology
- Review Panel
- PM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN200046 | Neurolutions Upper Extremity Rehabilitation System | Apr 23, 2021 | Unknown | Neurolutions, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.