Cleared Traditional

Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) (K231423) - FDA 510(k) Clearance

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

K231423 · Shenzhen Roundwhale Technology Co. , Ltd. · Neurology device
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Jan 2024
Decision
250d
Days
Class 2
Risk

K231423 is an FDA 510(k) clearance for the Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Roundwhale Technology Co. , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 22, 2024 after a review of 250 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 Roundwhale Technology Co. , Ltd. devices

Submission Details

510(k) Number K231423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2023
Decision Date January 22, 2024
Days to Decision 250 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
102d slower than avg
Panel avg: 148d · This submission: 250d
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 133
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K231423.
ENSO (Model 2)
K233784 · Hinge Health, Inc. · Feb 2024
EMS/TENS Massager Device
K233040 · Shenzhen Imdk Medical Technology Co., Ltd. · Feb 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092 · Chongqing Rob Linka Science and Technology Co., Ltd. · Feb 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461 · Hi-Dow International, Inc. · Jan 2024
Ova+ (K-OVAP-USA)
K230926 · Tenscare, Ltd. · Dec 2023
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
K232517 · Shenzhen Kentro Medical Electronics Co., Ltd. · Dec 2023