Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx— 510(k) K212071

Substantially Equivalent

Cefaly Technology

FDA 510(k) clearance K212071 for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx, Substantially Equivalent on 2022-12-13. Applicant: Cefaly Technology.

Clearance details

Applicant: Cefaly Technology
Product code: Code PCC
Advisory panel: Neurology
Date received: 2021-07-02
Decision date: 2022-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seraing, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code PCC

product code PCC

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.