Cleared Special

iStim S2 OTC Pain Relief TENS (K181849) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181849 · Everyway Medical Instruments Co., Ldt. · Neurology device
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Aug 2018
Decision
30d
Days
Class 2
Risk

K181849 is an FDA 510(k) clearance for the iStim S2 OTC Pain Relief TENS. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Everyway Medical Instruments Co., Ldt. (New Taipei City, TW). The FDA issued a Cleared decision on August 10, 2018 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Everyway Medical Instruments Co., Ldt. devices

Submission Details

510(k) Number K181849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2018
Decision Date August 10, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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

DuVal & Associates, P.A.
Aaron Hage

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 134
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K181849.
Everyway Wireless TENS & EMS Unit
K181707 · Everyway Medical Instruments Co.,Ltd · Sep 2018
ThermaCare Quick Therapy TENS
K181102 · Pfizer, Inc. · Sep 2018
Dual output digital therapy massager
K172834 · Shenzhen Osto Technology Co., Ltd. · Sep 2018
BMLS16-1
K172971 · Biomedical Life Systems, Inc. · Jul 2018
Wireless Pain Relieve Device
K180331 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2018
Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
K180956 · Shenzhen Roundwhale Technology Co. , Ltd. · Jun 2018