Cleared Traditional

K213091 - Well-Life TENS/EMS/Heating Stimulator

K213091 is the FDA 510(k) clearance for Well-Life TENS/EMS/Heating Stimulator by Well-Life Healthcare Limited. It is a Class 2 Neurology device (product code NUH) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K213091 · Well-Life Healthcare Limited · Neurology device
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Feb 2022
Decision
148d
Days
Class 2
Risk

K213091 is an FDA 510(k) clearance for the Well-Life TENS/EMS/Heating Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Well-Life Healthcare Limited (New Taipei City, TW). The FDA issued a Cleared decision on February 19, 2022 after a review of 148 days - within the typical 510(k) review window.

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 Well-Life Healthcare Limited devices

Submission Details

510(k) Number K213091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date February 19, 2022
Days to Decision 148 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
At panel average
Panel avg: 148d · This submission: 148d
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 K213091.
TENS & PMS Unit
K220005 · Shenzhen Yuehua Xinsen Technology Co., Ltd. · Apr 2022
TENS & EMS DEVICE (Model: FM-B2403A)
K213741 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
TENS & EMS Device
K213835 · Shenzhen Jian Feng Electronic Technology Co., Ltd. · Mar 2022
TENS & PMS (Model: SM9126)
K220150 · Hong Qiangxing (Shenzhen) Electronics Limited · Feb 2022
Intrelief
K211263 · Easymed Instruments Co., Ltd. · Dec 2021
Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
K212285 · Oriental Inspiration Limited · Dec 2021