Cleared Traditional

K002297 - YORAMED, MODEL T-202

K002297 is an FDA 510(k) clearance for YORAMED, manufactured by United Yoram Distributors, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K002297 · United Yoram Distributors, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
230d
Days
Class 2
Risk

K002297 is an FDA 510(k) clearance for the YORAMED, MODEL T-202. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by United Yoram Distributors, Inc. (Brooklyn, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 230 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K002297

510(k) Number K002297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2000
Decision Date March 15, 2001
Days to Decision 230 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
81d slower than avg
Panel avg: 149d · This submission: 230d
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 598
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K002297.
MULTI-STIM, MODEL MS-100
K001897 · Metron Medical Australia, Pty, Ltd. · Jun 2001
ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL
K010209 · Biomedical Life Systems, Inc. · Jun 2001
TRANSAMERICAN TENS
K010782 · Transamerica Medical Systems · Apr 2001
LIFECARE COMPACT TENS DEVICE
K003369 · Lifecare , Ltd. · Mar 2001
MEDRELIEF
K003507 · Healthonics, Inc. · Feb 2001
TENSCARE, MODEL TENS XL-2
K003591 · Tenscare, Ltd. · Feb 2001
K002297 · YORAMED, MODEL T-202
Download PDF FDA Summary United Yoram Distribu…