Cleared Traditional

K021952 - HIVOX DREAMATE DM-800

K021952 is an FDA 510(k) clearance for HIVOX DREAMATE DM-800, manufactured by Hivox Biotek, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K021952 · Hivox Biotek, Inc. · Neurology device
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May 2003
Decision
323d
Days
Class 2
Risk

K021952 is an FDA 510(k) clearance for the HIVOX DREAMATE DM-800. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Hivox Biotek, Inc. (Hsin-Chu City, TW). The FDA issued a Cleared decision on May 2, 2003 after a review of 323 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K021952

510(k) Number K021952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2002
Decision Date May 02, 2003
Days to Decision 323 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 148d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 147
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K021952.
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
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K033455 · Biomedical Life Systems, Inc. · Jan 2004
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K023913 · Bio-Medical Research, Ltd. · Aug 2003
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9
K022841 · Biomedical Life Systems, Inc. · Nov 2002
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10
K022925 · Biomedical Life Systems, Inc. · Nov 2002
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
K020749 · Everyway Medical Instruments Co.,Ltd · Oct 2002