# DEN200046: Neurolutions Upper Extremity Rehabilitation System

- Pathway: De Novo (Direct)
- Applicant: Neurolutions, Inc.
- Decided: Apr 23, 2021 after 274 days
- Product code: QOL (Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser)
- Device class: 2
- Regulation: 21 CFR 890.5420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Neurolutions IpsiHand Upper Extremity Rehabilitation System is indicated for use in chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity.

Source page: https://510kreport.com/device/DEN200046
Methodology: https://510kreport.com/methodology