Cleared Traditional

K193655 - MSLS6QF TENS/PMS Device

K193655 is the FDA 510(k) clearance for MSLS6QF TENS/PMS Device by Self Doctor Care, LLC. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K193655 · Self Doctor Care, LLC · Neurology device
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Sep 2020
Decision
249d
Days
Class 2
Risk

K193655 is an FDA 510(k) clearance for the MSLS6QF TENS/PMS Device. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Self Doctor Care, LLC (Frisco, US). The FDA issued a Cleared decision on September 4, 2020 after a review of 249 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 Self Doctor Care, LLC devices

Submission Details

510(k) Number K193655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2019
Decision Date September 04, 2020
Days to Decision 249 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
101d slower than avg
Panel avg: 148d · This submission: 249d
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 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 K193655.
Li-Battery powered OTC TENS/EMS Combination Stimulator
K201335 · Everyway Medical Instruments Co.,Ltd · Oct 2020
Transcutaneous Electronic Nerve Stimulator
K200237 · Shenzhen Kentro Medical Electronics Co., Ltd. · Oct 2020
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
K191982 · Shenzhen Kentro Medical Electronics Co., Ltd. · Sep 2020
Tyece OTC TENS Model
K200838 · Tyece Limited · Aug 2020
StimPlus Patch, StimPlus Patch, StimPlus Patch
K200561 · Jkh Health Co., Ltd. · Jul 2020
Electronic stimulator
K200354 · Shenzhen Dongjilian Electronics Co., Ltd. · Jun 2020