Cleared Traditional

Migraine Tens Digital Pain Reliever

K210364 · Shenzhen Dongdixin Technology Co., Ltd. · Neurology

Jun 2021

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K210364 is an FDA 510(k) clearance for the Migraine Tens Digital Pain Reliever, a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 17, 2021, 129 days after receiving the submission on February 8, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K210364 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2021
Decision Date	June 17, 2021
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5891
Definition	Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.