Cleared Traditional

K181102 - ThermaCare Quick Therapy TENS

K181102 is the FDA 510(k) clearance for ThermaCare Quick Therapy TENS by Pfizer, Inc.. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K181102 · Pfizer, Inc. · Neurology device
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Sep 2018
Decision
142d
Days
Class 2
Risk

K181102 is an FDA 510(k) clearance for the ThermaCare Quick Therapy TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on September 15, 2018 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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. Standard predicate reliance. 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 Pfizer, Inc. devices

Submission Details

510(k) Number K181102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2018
Decision Date September 15, 2018
Days to Decision 142 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
6d faster than avg
Panel avg: 148d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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 Consultant

Shenzhen Dongdixin Technology Co., Ltd.
Siping Yuan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 140
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K181102.
A6 OTC Pain Relief TENS
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K181707 · Everyway Medical Instruments Co.,Ltd · Sep 2018
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K172834 · Shenzhen Osto Technology Co., Ltd. · Sep 2018
iStim S2 OTC Pain Relief TENS
K181849 · Everyway Medical Instruments Co., Ldt. · Aug 2018
BMLS16-1
K172971 · Biomedical Life Systems, Inc. · Jul 2018