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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 the device name listed in this FDA 510(k) record. The listed applicant is Cefaly Technology. It received FDA 510(k) clearance on 2022-12-13 under 510(k) 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. The listed applicant is Cefaly Technology. The 510(k) number is K212071.

When did Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx receive FDA 510(k) clearance?

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 510(k) number K212071.

Who is the listed applicant for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx?

The FDA 510(k) record lists Cefaly Technology as the applicant. This does not by itself establish the device manufacturer.

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 records listing Cefaly Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234029CEFALY Connected - OTC, CEFALY Connected - RxK201895Cefaly DualK173006Cefaly DualK171446Cefaly AcuteK160237Cefaly

Related Devices (Code: PCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254216Enso for MigraineHinge Health, Inc.K242719ELEXIR 2.0 (ALLIVE3)Nu Eyne Co., Ltd.K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly TechnologyK232749DOOPANGYbrain, Inc.K233751Milieve (YPS-301BD)Soterix Medical, Inc.K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc.

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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