510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200046Unknown

Neurolutions Upper Extremity Rehabilitation System

Neurolutions, Santa Cruz CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN200046 is the FDA 510(k) clearance record for Neurolutions Upper Extremity Rehabilitation System, a class II device, cleared for Neurolutions, Inc. on under FDA product code QOL (Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser). FDA's definition for product code QOL 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...". FDA records list one 510(k) clearance for Neurolutions, Inc. As of , FDA records show no recalls naming DEN200046.

Clearance record

Decision date
Received
(274 days to decision)
Product code
QOL Electroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser
Regulation
21 CFR 890.5420
Device class
Class II
Review panel
Neurology
Applicant
Neurolutions, Inc. 1101 Pacific Ave., Suite 300, Santa Cruz CA
Third party review
No

Clearances, product code QOL

Trailing 12 months

FDA records hold no clearances under product code QOL in the trailing twelve months.

FDA records show no clearances under product code QOL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QOL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260