DEN220059 is an FDA 510(k) submission for the NTX100 Tonic Motor Activation (NTX100 ToMAc) System. This device is classified as a Stimulator, Nerve, For Restless Legs Syndrome (Class II - Special Controls, product code QWD).
Submitted by Noctrix Health, Inc. (Pleasanton, US). The FDA issued a Not Cleared (DENG) decision on April 17, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5887. 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..
| 510(k) Number | DEN220059 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 21, 2022 |
| Decision Date | April 17, 2023 |
| Days to Decision | 208 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QWD - Stimulator, Nerve, For Restless Legs Syndrome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5887 |
| Definition | 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. |