Cleared Traditional

K233046 - Electrical Neuromuscular Stimulator

K233046 is an FDA 510(k) clearance for Electrical Neuromuscular Stimulator, manufactured by Oriental Inspiration Limited. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K233046 · Oriental Inspiration Limited · Neurology device
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Apr 2024
Decision
207d
Days
Class 2
Risk

K233046 is an FDA 510(k) clearance for the Electrical Neuromuscular Stimulator, Cure Trio. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Oriental Inspiration Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 19, 2024 after a review of 207 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 Oriental Inspiration Limited devices

FDA 510(k) Submission Details - K233046

510(k) Number K233046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date April 19, 2024
Days to Decision 207 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
59d slower than avg
Panel avg: 148d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 146
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K233046.
CP Relief Wand Rx - TENS/NMES
K252236 · N & C Holdings, LLC · Aug 2025
Unipro (K-UNIPRO-US)
K232441 · Tenscare, Ltd. · Aug 2024
TENSWave
K241228 · Zynex Medical Officer · Aug 2024
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Jan 2023
iRelieve Microcurrent Pain Relief System
K212618 · Fast Track Technologies, Inc. · Sep 2022
StimOnTM Pain Relief System (GM2439)
K213802 · Gimer Medical Co., Ltd. · Aug 2022