Cleared Traditional

K021430 - SANIDAD TENS-DUO MODE GP8016N

K021430 is an FDA 510(k) clearance for SANIDAD TENS-DUO MODE GP8016N, manufactured by Rolor Electronics Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K021430 · Rolor Electronics Corp. · Neurology device
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Dec 2002
Decision
213d
Days
Class 2
Risk

K021430 is an FDA 510(k) clearance for the SANIDAD TENS-DUO MODE GP8016N. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Rolor Electronics Corp. (Hsin-Chu City, TW). The FDA issued a Cleared decision on December 2, 2002 after a review of 213 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.

FDA 510(k) Submission Details - K021430

510(k) Number K021430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date December 02, 2002
Days to Decision 213 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
64d slower than avg
Panel avg: 149d · This submission: 213d
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 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K021430.
MEDS-4 NEUROMUSCULAR STIMULATOR
K023435 · Medical Equipment Device Specialists · Jan 2003
MEDS-3 NEUROMUSCULAR STIMULATOR
K023443 · Medical Equipment Device Specialists · Jan 2003
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
K020020 · Well-Life Healthcare, Inc. · Dec 2002
804SIII
K021846 · Body Clock Health Care, Ltd. · Nov 2002
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
K021430 · SANIDAD TENS-DUO MODE GP8016N
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