Cleared Traditional

TENS device-HeadaTerm 2 (Model: YF-HT2)

K230782 · Wat Medical Technology, Inc. · Neurology

Feb 2024

Decision

341d

Days

Class 2

Risk

About This 510(k) Submission

K230782 is an FDA 510(k) clearance for the TENS device-HeadaTerm 2 (Model: YF-HT2), a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Wat Medical Technology, Inc. (Ningbo, CN). The FDA issued a Cleared decision on February 26, 2024, 341 days after receiving the submission on March 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K230782 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 22, 2023
Decision Date	February 26, 2024
Days to Decision	341 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.