Cefaly Acute

Q: When was Cefaly Acute cleared by the FDA?

Cefaly Acute (K171446) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 122 days after the submission was received.

Q: What is the product code of K171446?

The FDA product code is PCC – Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, a Class II (moderate risk) device regulated under 21 CFR 882.5891.

FDA 510(k) K171446 · Cefaly Technology

Substantially Equivalent

510(k) numberK171446

Submission

Device name: Cefaly Acute
Applicant: Cefaly Technology
Seraing, BE
Received: May 16, 2017
Decision date: September 15, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PCC – Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5891
Specialty: Neurology

Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Other 510(k)s with product code PCC

510(k)	Device	Applicant	Decision
K254216	Enso for MigrainePCC · Traditional	Hinge Health, Inc.	04/16/2026SE
K242719	Elexir 2.0 (ALLIVE3)PCC · Traditional	Nu Eyne Co., Ltd.	11/06/2024SE
K234029	CEFALY Connected - OTC, CEFALY Connected - RxPCC · Traditional	Cefaly Technology	07/18/2024SE
K232749	DoopangPCC · Traditional	Ybrain, Inc.	06/11/2024SE
K233751	Milieve (YPS-301BD)PCC · Traditional	Soterix Medical, Inc.	06/03/2024SE
K230782	TENS device-HeadaTerm 2 (Model: YF-HT2)PCC · Traditional	Wat Medical Technology, Inc.	02/26/2024SE
K212071	Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…PCC · Traditional	Cefaly Technology	12/13/2022SE
K212106	RelivionPCC · Special	Neurolief , Ltd.	08/02/2021SE
K211380	ElexirPCC · Traditional	Nu Eyne Co., Ltd.	07/30/2021SE
K210364	Migraine Tens Digital Pain RelieverPCC · Traditional	Shenzhen Dongdixin Technology Co., Ltd.	06/17/2021SE

More from Shenzhen Dongdixin Technology Co., Ltd.

510(k)	Device	Decision
K234029	CEFALY Connected - OTC, CEFALY Connected - RxPCC · Traditional	07/18/2024SE
K212071	Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…PCC · Traditional	12/13/2022SE
K201895	Cefaly DualPCC · Traditional	09/29/2020SE
K173006	Cefaly DualPCC · Traditional	11/28/2017SE
K160237	CefalyPCC · Special	03/04/2016SE

Questions and answers

When was Cefaly Acute cleared by the FDA?

Cefaly Acute (K171446) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 122 days after the submission was received.

What is the product code of K171446?

The FDA product code is PCC – Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, a Class II (moderate risk) device regulated under 21 CFR 882.5891.