Cleared Traditional

K011891 - PANAG

K011891 is an FDA 510(k) clearance for PANAG, manufactured by Panag International. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K011891 · Panag International · Neurology device
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Jul 2002
Decision
407d
Days
Class 2
Risk

K011891 is an FDA 510(k) clearance for the PANAG. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Panag International (Johannesburg, ZA). The FDA issued a Cleared decision on July 30, 2002 after a review of 407 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K011891

510(k) Number K011891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2001
Decision Date July 30, 2002
Days to Decision 407 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
258d slower than avg
Panel avg: 149d · This submission: 407d
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 588
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K011891.
ULTRASTIM KIT
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NT MEDITENS PLUS, TYPE 290
K014020 · Bio-Medical Research, Ltd. · Jul 2002
APEX MEDICAL DIGITAL TENS TS1211, TS1212
K021755 · Apex Medical Corp. · Jun 2002
K011891 · PANAG
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