Cleared Traditional

K982436 - RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R

K982436 is an FDA 510(k) clearance for RELIEFBAND NST DEVICE, manufactured by Woodside Biomedical, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K982436 · Woodside Biomedical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
86d
Days
Class 2
Risk

K982436 is an FDA 510(k) clearance for the RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Woodside Biomedical, Inc. (San Diego, US). The FDA issued a Cleared decision on October 8, 1998 after a review of 86 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 Woodside Biomedical, Inc. devices

FDA 510(k) Submission Details - K982436

510(k) Number K982436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1998
Decision Date October 08, 1998
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 183
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K982436.
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