FDA device listing
CEFALY Connected and CeCe Migraine Management App
FDA device listing 1309751815 · Blue Ocean Innovation Limited
Key facts
| Proprietary names | CEFALY Connected and CeCe Migraine Management App |
|---|---|
| Owner/operator | Blue Ocean Innovation Limited |
| Owner/operator number | 9054823 |
| Product codes | PCC |
| Device names | PCC - Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.5891 |
| Review panels | Neurology |
| Registered establishments | JDI ELECTRONICS FACTORY |
| Establishment registrations | 3003927385 |
| FEI numbers | 3003927385 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database