Neuromodulation devices on FDA's records
Two De Novo grants created the main classifications for wearable migraine stimulators:
- CEFALY (DEN120019, 2014): "stimulator, nerve, electrical, transcutaneous, for migraine," 21 CFR 882.5891, product code PCC.
- Nerivio Migra (DEN180059, 2019): "distal transcutaneous electrical stimulator for treatment of acute migraine," 21 CFR 882.5899, product code QGT.
The table is a partial list of authorizations under these codes, oldest first. We have not summarized each device's indications, which changed across later clearances: read each summary on FDA's database. Clearance or a De Novo grant is not FDA approval.
| Device | Number | Regulation (product code) | Decision date |
|---|---|---|---|
| CEFALY | DEN120019 (De Novo) | 882.5891 (PCC) | 2014-03-11 |
| Cefaly Acute | K171446 | 882.5891 (PCC) | 2017-09-15 |
| Cefaly Dual | K173006 | 882.5891 (PCC) | 2017-11-28 |
| Nerivio Migra | DEN180059 (De Novo) | 882.5899 (QGT) | 2019-05-20 |
| Nerivio | K203181 | 882.5899 (QGT) | 2021-01-22 |
| Relivion | K203419 | 882.5891 (PCC) | 2021-02-16 |
| Relivion | K212106 | 882.5891 (PCC) | 2021-08-02 |
| Nerivio | K223169 | 882.5899 (QGT) | 2023-02-06 |
| CEFALY Connected - OTC / Rx | K234029 | 882.5891 (PCC) | 2024-07-18 |
| Nerivio; Nerivio Infinity | K241756 | 882.5899 (QGT) | 2024-10-08 |
| Nerivio; Nerivio Infinity | K250405 | 882.5899 (QGT) | 2025-05-14 |
Sources: FDA De Novo DEN120019; FDA De Novo DEN180059; later clearances checked on the FDA 510(k) database. This page is a summary, not medical advice.
Can apps predict migraine attacks from triggers?
A 90-day prospective daily-diary cohort study, run through a custom iPhone research app, modeled attack risk from self-reported "stress, sleep, caffeine and alcohol consumption, menstruation, and self-prediction." Across 178 participants and 1,870 migraine events, the model "predicted migraine risk only slightly better than chance (within-person C-statistic: 0.56, 95% CI: 0.54, 0.58)." The authors concluded that "episodic migraine attacks were not predictable based on self-prediction or on self-reported exposure to common trigger factors."
Source: Holsteen et al., Headache 2020 (abstract).
What it means for startups
Our reading (editorial, not from a source):
- Stimulation devices have established codes. PCC and QGT give a new device predicates to compare against.
- Be careful with prediction claims. At least one prospective study found self-reported triggers barely beat chance; validate before promising forecasts.
- Report within-person performance, since attack risk varies within each patient over time.
Related resources
Frequently asked questions
Are there FDA-authorized wearables for migraine?
Yes. CEFALY received a De Novo grant in 2014 (product code PCC) and Nerivio Migra in 2019 (product code QGT), with later 510(k) clearances under both codes.
Can an app predict migraine attacks from triggers?
A 2020 prospective study of 178 people found self-reported triggers and self-prediction predicted attacks only slightly better than chance (within-person C-statistic 0.56).
Is a migraine stimulator FDA-approved?
These devices were granted De Novo or cleared through 510(k), which is not the same as FDA approval. Read each summary for its indications.
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