# DEN170023: ThermoNeuroModulation Device, TNM Device

- Pathway: De Novo (Direct)
- Applicant: Scion Neurostim, LLC
- Decided: Mar 26, 2018 after 343 days
- Product code: QAR (Thermal Vestibular Stimulator For Headache)
- Device class: 2
- Regulation: 21 CFR 882.5893
- 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 TNM Device is intended to stimulate the vestibular system using tightly controlled thermal waveforms. The TNM Device is indicated for the prophylactic treatment of episodic migraine in adolescent and adult patients 12 years or older.

Source page: https://510kreport.com/device/DEN170023
Methodology: https://510kreport.com/methodology