Cleared Traditional

K261574 - Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)

K261574 is an FDA 510(k) clearance for Wireless TENS&EMS&NMES Heating Stimulat..., manufactured by Hong Qiangxing (Shenzhen) Electronics Limited. 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.

K261574 · Hong Qiangxing (Shenzhen) Electronics Limited · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
157d
Days
Class 2
Risk

K261574 is an FDA 510(k) clearance for the Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, .... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hong Qiangxing (Shenzhen) Electronics Limited (Shenzhen, CN). The FDA issued a Cleared decision on October 16, 2026 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.

FDA 510(k) Submission Details - K261574

510(k) Number K261574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2026
Decision Date October 16, 2026
Days to Decision 157 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 149d · 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 230
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K261574.
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J
K261131 · Shenzhen Osto Medical Technology Co.,Ltd · Sep 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2026
TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)
K260425 · Hivox Biotek, Inc. · Jun 2026
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
VEINOPLUS Back
K251958 · Dynapulse Medical · Dec 2025
K261574 · Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143)
Download PDF FDA Summary Hong Qiangxing (Shenz…