# DEN220059: NTX100 Tonic Motor Activation (NTX100 ToMAc) System

- Pathway: De Novo (Direct)
- Applicant: Noctrix Health, Inc.
- Decided: Apr 17, 2023 after 208 days
- Product code: QWD (Stimulator, Nerve, For Restless Legs Syndrome)
- Device class: 2
- Regulation: 21 CFR 882.5887
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The NTX100 Tonic Motor Activation (ToMAc) System is intended to reduce symptoms of primary moderate-severe Restless Leg Syndrome and to improve sleep quality in adults refractory to medications.

Source page: https://510kreport.com/device/DEN220059
Methodology: https://510kreport.com/methodology