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FDA 510(k)

Cefaly Acute

K-Number: K171446 · 2017-09-15

ApplicantCefaly Technology
Decision Date2017-09-15
Product CodePCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cefaly Acute is a medical device manufactured by Cefaly Technology. It received FDA 510(k) clearance on 2017-09-15 under approval number K171446. 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 Acute?

Cefaly Acute is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Cefaly Technology. The 510(k) number is K171446.

When was Cefaly Acute approved by the FDA?

Cefaly Acute received FDA 510(k) clearance on 2017-09-15, under approval number K171446.

What company makes Cefaly Acute?

Cefaly Acute is manufactured by Cefaly Technology.

What is the FDA product code for Cefaly Acute?

The FDA product code for Cefaly Acute is PCC.

Other Devices by Cefaly Technology

K160237Cefaly K173006Cefaly Dual K201895Cefaly Dual K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx K234029CEFALY Connected - OTC, CEFALY Connected - Rx

Related Devices (Code: PCC)

K160237CefalyCefaly Technology K173006Cefaly DualCefaly Technology K172450TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd. K192773ALLIVENu Eyne Co., Ltd. K201895Cefaly DualCefaly Technology K212106RelivionNeurolief , Ltd.

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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