Cleared Traditional

HIVOX OTC Electrical Stimulator, FT610-B (K211403) - FDA 510(k) Clearance

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

K211403 · Hivox Biotek, Inc. · Neurology device
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Oct 2021
Decision
162d
Days
Class 2
Risk

K211403 is an FDA 510(k) clearance for the HIVOX OTC Electrical Stimulator, FT610-B. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hivox Biotek, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on October 15, 2021 after a review of 162 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 Hivox Biotek, Inc. devices

Submission Details

510(k) Number K211403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2021
Decision Date October 15, 2021
Days to Decision 162 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
14d slower than avg
Panel avg: 148d · This submission: 162d
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 K211403.
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
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
K202671 · Guangzhou Xinbo Electronic Co., Ltd. · Nov 2021
Smart Neck Stimulator
K200558 · Guandong Skg Intelligent Technology Co., Ltd. · 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