QWD · Class II · 21 CFR 882.5887

FDA Product Code QWD: Stimulator, Nerve, For Restless Legs Syndrome

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.

Leading manufacturers include Noctrix Health, Inc..

1
Total
0
Cleared
208d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Stimulator, Nerve, For Restless Legs Syndrome Devices (Product Code QWD)

1 devices
1–1 of 1
Not Cleared Apr 17, 2023
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
DEN220059
Noctrix Health, Inc.
Neurology · 208d

About Product Code QWD - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QWD since 2023, with 0 receiving FDA clearance (average review time: 208 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QWD devices are reviewed by the Neurology panel. Browse all Neurology devices →