Identifiers
- 510(k) Number
- K192773 FDA 510(k)
- FDA Product Code
- PCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5891 FDA 510(k)
- Regulation Number
- 882.5891 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ALLIVE is a transcutaneous electrical nerve stimulator for migraine treatment. It is a Class II medical device with product code PCC, designed to stimulate nerves through the skin to alleviate headache symptoms.
The device is manufactured by Nu Eyne Co., Ltd. and received FDA 510(k) clearance on December 6, 2019. It is regulated under 21 CFR 882.5891 and reviewed by the Neurology advisory committee. The device is supplied in various sizes as indicated by the multiple registration numbers provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALLIVE (K192773) — FDA 510 (k) | Innolitics, ALLIVE 510 (k) K192773 - FDA.report, ALLIVE — FDA 510 (k) K192773 | MedTracker - aiqixie.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192773 | Class II | Active |
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Manufacturer
- Manufacturer
- Nu Eyne Co., Ltd.
Sources (1)
- FDA 510(k) K192773 24 fields · synced Sep 27, 2026