Cleared Traditional

K012643 - APEX MEDICAL LCD TENS-VII

K012643 is the FDA 510(k) clearance for APEX MEDICAL LCD TENS-VII by Apex Medical Corp.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K012643 · Apex Medical Corp. · Neurology device
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Oct 2001
Decision
77d
Days
Class 2
Risk

K012643 is an FDA 510(k) clearance for the APEX MEDICAL LCD TENS-VII. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on October 29, 2001 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apex Medical Corp. devices

Submission Details

510(k) Number K012643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date October 29, 2001
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 148d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 139
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K012643.
NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp. · Jun 2002
APEX MEDICAL MINI TENS
K020032 · Apex Medical Corp. · Jan 2002
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp. · Oct 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
STIMATE N601 TENS
K003487 · Everyway Medical Instruments Co.,Ltd · Jan 2001