Cleared Traditional

K233095 - S21 OTC Transcutaneous Electrical Nerve...

K233095 is an FDA 510(k) clearance for S21 OTC Transcutaneous Electrical Nerve..., manufactured by Micro Current Technology, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K233095 · Micro Current Technology, Inc. · Neurology device
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Mar 2024
Decision
157d
Days
Class 2
Risk

K233095 is an FDA 510(k) clearance for the S21 OTC Transcutaneous Electrical Nerve Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Micro Current Technology, Inc. (Seattle, US). The FDA issued a Cleared decision on March 1, 2024 after a review of 157 days - an extended review cycle.

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 Micro Current Technology, Inc. devices

FDA 510(k) Submission Details - K233095

510(k) Number K233095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date March 01, 2024
Days to Decision 157 days
Submission Type Traditional
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
9d slower than avg
Panel avg: 148d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

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

All 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K233095.
Transcutaneous Electrical Nerve Stimulator (9029SCM)
K240292 · Hong Kong Etech Groups Limited · Mar 2024
Electrical Stimulator System
K232439 · Gymmax Technology Shenzen Co., Ltd. · Mar 2024
Muscle Stimulator
K231648 · Shenzhen Yiran Intelligent Co., Ltd. · Mar 2024
ENSO (Model 2)
K233784 · Hinge Health, Inc. · Feb 2024
EMS/TENS Massager Device
K233040 · Shenzhen Imdk Medical Technology Co., Ltd. · Feb 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092 · Chongqing Rob Linka Science and Technology Co., Ltd. · Feb 2024