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Neurolutions Upper Extremity Rehabilitation System

DEN200046 Class II Direct
Decision Date
2021-04-23
Sponsor / Applicant
Neurolutions, Inc.

Technical Specification

510(k) Submission ID DEN200046
Product Code QOL
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 890.5420
Decision Date 2021-04-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Neurolutions Upper Extremity Rehabilitation System received FDA 510(k) clearance under submission number DEN200046, sponsored by Neurolutions, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-04-23.

Classification & Regulation

This clearance is catalogued under FDA product code QOL and 21 CFR 890.5420, within the Neurology review panel as a Class II device.