QOLClass II

Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser

21 CFR 890.5420 / Neurology

QOL is the FDA product code for Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser, a class II device type, regulated under 21 CFR 890.5420. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2021-04-23, and no recalls.

Classification record

Product code: QOL
Device name: Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
FDA 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.
Regulation: 21 CFR 890.5420
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QOL

By decision year

1 clearance under product code QOL with a decision year between 2021 and 2021, 2021 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QOL by decision year
Year	Clearances
2021	1

Applicants with the most clearances

Product code QOL

Applicants holding the most 510(k) clearances under product code QOL
Applicant	Clearances
Neurolutions	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Neurolutions

Recent clearances

Product code QOL

DEN200046Class IINeurolutions Upper Extremity Rehabilitation SystemNeurolutions, Inc. / cleared 2021-04-23

Recent recalls

Product code QOL

FDA records show no recalls under product code QOL.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)