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510(k) DEN220059

NTX100 Tonic Motor Activation (NTX100 ToMAc) System by Noctrix Health, Inc. — Product Code QWD

DEN220059 is an FDA 510(k) premarket notification submitted by Noctrix Health, Inc. for the device "NTX100 Tonic Motor Activation (NTX100 ToMAc) System". The FDA issued a decision of De Novo Granted on April 17, 2023. The device falls under product code QWD (Stimulator, Nerve, For Restless Legs Syndrome), a Class II device regulated under 21 CFR 882.5887.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 17, 2023
Date Received
September 21, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, For Restless Legs Syndrome
Device Class
Class II
Regulation Number
882.5887
Review Panel
NE
Submission Type

An external lower extremity nerve stimulator for Restless Legs Syndrome is a prescription device that uses external electrical stimulators and cutaneous electrodes to stimulate nerves in the lower extremity (e.g.,peroneal nerves) and evoke tonic, sustained muscle activation in the legs to reduce the symptoms of Restless Legs Syndrome.

FDA data resources