DeviceClearance

Product code QWD— Neurology

NTX100 Tonic Motor Activation (NTX100 ToMAc) System

Classification name
Stimulator, Nerve, For Restless Legs Syndrome
Device class
Class 2
Regulation
21 CFR 882.5887
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QWD under 21 CFR 882.5887, via openFDA

Market context for product code QWD

FDA has cleared 1 device under product code QWD, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QWD

Recent clearances under product code QWD

Data sourced from openFDA. This site is unofficial and independent of the FDA.