Cleared Traditional

K233046 - Electrical Neuromuscular Stimulator, Cure Trio (FDA 510(k) Clearance)

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

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

Submission Details

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.

Device Classification

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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K233046.
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K252767 · Sublimed · Jan 2026
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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