Cleared Traditional

K193655 - MSLS6QF TENS/PMS Device

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

K193655 · Self Doctor Care, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K193655

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.

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 219
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