Cleared Traditional

Smart Neck Stimulator (K200558) - FDA 510(k) Clearance

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

K200558 · Guandong Skg Intelligent Technology Co., Ltd. · Neurology device
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Oct 2021
Decision
580d
Days
Class 2
Risk

K200558 is an FDA 510(k) clearance for the Smart Neck Stimulator. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Guandong Skg Intelligent Technology Co., Ltd. (Shunde District, Foshan City, CN). The FDA issued a Cleared decision on October 4, 2021 after a review of 580 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Guandong Skg Intelligent Technology Co., Ltd. devices

Submission Details

510(k) Number K200558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2020
Decision Date October 04, 2021
Days to Decision 580 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
432d slower than avg
Panel avg: 148d · This submission: 580d
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 K200558.
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989 · Shenzhen Osto Technology Co., Ltd. · Nov 2021
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
K202671 · Guangzhou Xinbo Electronic Co., Ltd. · Nov 2021
HIVOX OTC Electrical Stimulator, FT610-B
K211403 · Hivox Biotek, Inc. · Oct 2021
Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
K211736 · Shenzhen Osto Technology Company Limited · Sep 2021
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
K210756 · Shenzhen Osto Technology Company Limited · Jun 2021
Perfect EMS
K200694 · Tenscare, Ltd. · Jun 2021