Migraine Tens Digital Pain Reliever

Q: What is the product code of K210364?

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) K210364 · Shenzhen Dongdixin Technology Co., Ltd.

Substantially Equivalent

510(k) numberK210364

Submission

Device name: Migraine Tens Digital Pain Reliever
Applicant: Shenzhen Dongdixin Technology Co., Ltd.
Shenzhen, CN
Received: February 8, 2021
Decision date: June 17, 2021
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
K203419	RelivionPCC · Traditional	Neurolief , Ltd.	02/16/2021SE

More from Neurolief , Ltd.

510(k)	Device	Decision
K260412	TENS 7000 Rechargeable 4 Channel (TENS 7000H)NUH · Traditional	06/26/2026SE
K240358	ShockPhysio Mobile (model SW3200 Basic)ISA · Traditional	06/05/2024SE
K213043	Levator Elite (Model LE9011)IPF · Traditional	02/25/2022SE
K180331	Wireless Pain Relieve DeviceNUH · Traditional	06/22/2018SE
K171430	Incontinence Treatment Device, Model LT2061KPI · Traditional	03/15/2018SE
K173462	Wireless Pain Relieve Device Model: LT5018CNUH · Special	12/08/2017SE
K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10IPF · Traditional	10/02/2017SE
K162479	Smart Pain Reliever, Model LT5019NUH · Traditional	02/08/2017SE
K161735	Non-contact Forehead ThermometerFLL · Traditional	11/17/2016SE
K150436	ComboRehabIMG · Traditional	11/13/2015SE

Questions and answers

When was Migraine Tens Digital Pain Reliever cleared by the FDA?

Migraine Tens Digital Pain Reliever (K210364) received a 510(k) decision of Substantially Equivalent on June 17, 2021, 129 days after the submission was received.

What is the product code of K210364?

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