Cleared Traditional

K243856 - TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)

K243856 is an FDA 510(k) clearance for TENS AND EMS (TENS and Muscle Stimulato..., manufactured by Shenzhen Astec Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K243856 · Shenzhen Astec Technology Co., Ltd. · Neurology device
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May 2025
Decision
164d
Days
Class 2
Risk

K243856 is an FDA 510(k) clearance for the TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS902.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Astec Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 29, 2025 after a review of 164 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 Shenzhen Astec Technology Co., Ltd. devices

FDA 510(k) Submission Details - K243856

510(k) Number K243856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2024
Decision Date May 29, 2025
Days to Decision 164 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 149d · This submission: 164d
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 229
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K243856.
OTC 4-Channel Rechargeable TENS Unit
K251429 · Changsha Anxiang Medical Technology Co., Ltd. · Aug 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122)
K250784 · Shenzhen Yicai Health Technology Co., Ltd. · Aug 2025
3 in 1 TENS UNIT (TC1241, TC2241, TS1241)
K251187 · Changsha Anxiang Medical Technology Co., Ltd. · Jul 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
K250360 · Shenzhen Jiantuo Electronics Co., Ltd. · May 2025
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
K250053 · Shenzhen Jiantuo Electronics Co., Ltd. · May 2025
Patch-TEA (Model TRI-21)
K243613 · Transtimulation Research, Inc. · Apr 2025