Cleared Traditional

K212285 - Electrical Neuromuscular Stimulator (Cu...

K212285 is an FDA 510(k) clearance for Electrical Neuromuscular Stimulator (Cu..., manufactured by Oriental Inspiration Limited. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K212285 · Oriental Inspiration Limited · Neurology device
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Dec 2021
Decision
154d
Days
Class 2
Risk

K212285 is an FDA 510(k) clearance for the Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 A.... Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Oriental Inspiration Limited (Hong Kong, CN). The FDA issued a Cleared decision on December 22, 2021 after a review of 154 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 - K212285

510(k) Number K212285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2021
Decision Date December 22, 2021
Days to Decision 154 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
6d slower than avg
Panel avg: 148d · This submission: 154d
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 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K212285.
Well-Life TENS/EMS/Heating Stimulator
K213091 · Well-Life Healthcare Limited · Feb 2022
TENS & PMS (Model: SM9126)
K220150 · Hong Qiangxing (Shenzhen) Electronics Limited · Feb 2022
Intrelief
K211263 · Easymed Instruments Co., Ltd. · Dec 2021
Transcutaneous Electrical Nerve Stimulator
K210223 · Top-Rank Health Care Co., Ltd. · Dec 2021
Heat StimPlus
K212918 · Famidoc Technology Co., Ltd. · Dec 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989 · Shenzhen Osto Technology Co., Ltd. · Nov 2021