Cleared Traditional

TENS & EMS DEVICE (Model: FM-B2403A) (K213741) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213741 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Physical Medicine device
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Mar 2022
Decision
99d
Days
Class 2
Risk

K213741 is an FDA 510(k) clearance for the TENS & EMS DEVICE (Model: FM-B2403A). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Jian Feng Electronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 8, 2022 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Jian Feng Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K213741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2021
Decision Date March 08, 2022
Days to Decision 99 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 Physical Medicine devices follow this clearance model.

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

All 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K213741.
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
K212377 · Ningbo Medkinetic Medical Device Co., Ltd. · Apr 2022
TENS and EMS Stimulation (OTC)
K212184 · Changsha Yuwen Medical Equipment Co., Ltd. · Apr 2022
TENS & PMS Unit
K220005 · Shenzhen Yuehua Xinsen Technology Co., Ltd. · Apr 2022
TENS & EMS Device
K213835 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
Well-Life TENS/EMS/Heating Stimulator
K213091 · Well-Life Healthcare Limited · Feb 2022
TENS & PMS (Model: SM9126)
K220150 · Hong Qiangxing (Shenzhen) Electronics Limited · Feb 2022