Cleared Traditional

K233040 - EMS/TENS Massager Device

K233040 is an FDA 510(k) clearance for EMS/TENS Massager Device, manufactured by Shenzhen Imdk Medical Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code NUH cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K233040 · Shenzhen Imdk Medical Technology Co., Ltd. · Physical Medicine device
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Feb 2024
Decision
140d
Days
Class 2
Risk

K233040 is an FDA 510(k) clearance for the EMS/TENS Massager Device. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 12, 2024 after a review of 140 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 Imdk Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K233040

510(k) Number K233040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date February 12, 2024
Days to Decision 140 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 115d · This submission: 140d
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K233040.
Muscle Stimulator
K231648 · Shenzhen Yiran Intelligent Co., Ltd. · Mar 2024
S21 OTC Transcutaneous Electrical Nerve Stimulator
K233095 · Micro Current Technology, Inc. · Mar 2024
ENSO (Model 2)
K233784 · Hinge Health, Inc. · Feb 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092 · Chongqing Rob Linka Science and Technology Co., Ltd. · Feb 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
K231423 · Shenzhen Roundwhale Technology Co. , Ltd. · Jan 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461 · Hi-Dow International, Inc. · Jan 2024