Cleared Traditional

K980333 - RELIEFBAND

K980333 is an FDA 510(k) clearance for RELIEFBAND, 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 21-day FDA review.

K980333 · Woodside Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
21d
Days
Class 2
Risk

K980333 is an FDA 510(k) clearance for the RELIEFBAND. 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 February 18, 1998 after a review of 21 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 - K980333

510(k) Number K980333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1998
Decision Date February 18, 1998
Days to Decision 21 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
127d faster than avg
Panel avg: 148d · This submission: 21d
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 K980333.
MULTI-STIM TENS, AP-101081T
K973979 · Apex Medical Corp. · Jul 1998
ACU-STIM TENS, AP-101082T
K973980 · Apex Medical Corp. · Jul 1998
NT2000
K972244 · Bio-Medical Research, Ltd. · Feb 1998
INTELECT
K974497 · Chattanooga Group, Inc. · Jan 1998
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K965244 · Z Technologies, LLC · Aug 1997
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K965187 · Sparta Surgical Corp. · Aug 1997