Cleared Traditional

K994387 - RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL

K994387 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 79-day FDA review.

K994387 · Woodside Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
79d
Days
Class 2
Risk

K994387 is an FDA 510(k) clearance for the RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Woodside Biomedical, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 16, 2000 after a review of 79 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.

FDA 510(k) Submission Details - K994387

510(k) Number K994387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date March 16, 2000
Days to Decision 79 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
70d faster than avg
Panel avg: 149d · This submission: 79d
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 449
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K994387.
MEDISANA DIGITAL TENS
K994265 · Fuji Dynamics Limited · Jul 2000
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K994266 · Fuji Dynamics Limited · Jul 2000
ENDOR 2000
K984376 · T.C. Medical, Inc. · Jun 2000
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
K991397 · Sein Electronics Co., Ltd. · Feb 2000
RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
K983907 · Woodside Biomedical, Inc. · Dec 1999
MED-4000
K993823 · Micro Current Technology, Inc. · Nov 1999
K994387 · RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
Download PDF FDA Summary Woodside Biomedical, …