Cleared Traditional

K172450 - TENS device-HeadaTerm, eEspress

K172450 is an FDA 510(k) clearance for TENS device-HeadaTerm, manufactured by Wat Medical Technology (Ningbo) Co., Ltd.. The device is a Class 2 Neurology device with product code PCC cleared through the Traditional 510(k) pathway after a 395-day FDA review.

K172450 · Wat Medical Technology (Ningbo) Co., Ltd. · Neurology device
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Sep 2018
Decision
395d
Days
Class 2
Risk

K172450 is an FDA 510(k) clearance for the TENS device-HeadaTerm, eEspress. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Wat Medical Technology (Ningbo) Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on September 13, 2018 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wat Medical Technology (Ningbo) Co., Ltd. devices

FDA 510(k) Submission Details - K172450

510(k) Number K172450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date September 13, 2018
Days to Decision 395 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
247d slower than avg
Panel avg: 148d · This submission: 395d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PCC Device Classification - Class 2, Special Controls

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
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