Cleared Traditional

K212918 - Heat StimPlus

K212918 is an FDA 510(k) clearance for Heat StimPlus, manufactured by Famidoc Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K212918 · Famidoc Technology Co., Ltd. · Neurology device
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Dec 2021
Decision
90d
Days
Class 2
Risk

K212918 is an FDA 510(k) clearance for the Heat StimPlus. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Famidoc Technology Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on December 13, 2021 after a review of 90 days - within the typical 510(k) review window.

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 Famidoc Technology Co., Ltd. devices

FDA 510(k) Submission Details - K212918

510(k) Number K212918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2021
Decision Date December 13, 2021
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 K212918.
Intrelief
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Low-frequency Stimulator (Model: AST-645, AST-646)
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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