Cleared Traditional

K211403 - HIVOX OTC Electrical Stimulator

K211403 is an FDA 510(k) clearance for HIVOX OTC Electrical Stimulator, manufactured by Hivox Biotek, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K211403 · Hivox Biotek, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K211403

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.

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 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