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FDA 510(k)

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

K-Number: K212071 · 2022-12-13

ApplicantCefaly Technology
Decision Date2022-12-13
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx is a medical device manufactured by Cefaly Technology. It received FDA 510(k) clearance on 2022-12-13 under approval number K212071. The device is classified under product code PCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx?

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx is a medical device that received FDA 510(k) clearance on 2022-12-13. It is manufactured by Cefaly Technology. The 510(k) number is K212071.

When was Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx approved by the FDA?

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx received FDA 510(k) clearance on 2022-12-13, under approval number K212071.

What company makes Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx?

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx is manufactured by Cefaly Technology.

What is the FDA product code for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx?

The FDA product code for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx is PCC.

Other Devices by Cefaly Technology

K160237Cefaly K173006Cefaly Dual K171446Cefaly Acute K201895Cefaly Dual K234029CEFALY Connected - OTC, CEFALY Connected - Rx

Related Devices (Code: PCC)

K160237CefalyCefaly Technology K173006Cefaly DualCefaly Technology K171446Cefaly AcuteCefaly Technology K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd. K192773ALLIVENu Eyne Co., Ltd. K201895Cefaly DualCefaly Technology

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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