Cleared Traditional

K173233 - ReliefBand 1.5

K173233 is an FDA 510(k) clearance for ReliefBand 1.5, manufactured by Reliefband Technologies. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K173233 · Reliefband Technologies · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
56d
Days
Class 2
Risk

K173233 is an FDA 510(k) clearance for the ReliefBand 1.5. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Reliefband Technologies (Horsham, US). The FDA issued a Cleared decision on November 30, 2017 after a review of 56 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 - K173233

510(k) Number K173233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2017
Decision Date November 30, 2017
Days to Decision 56 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
93d faster than avg
Panel avg: 149d · This submission: 56d
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 Consultant

Whitman Regulatory Consulting
Barbara Whitman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 383
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K173233.
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