Cleared Traditional

K972244 - NT2000

K972244 is the FDA 510(k) clearance for NT2000 by Bio-Medical Research, Ltd.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K972244 · Bio-Medical Research, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
256d
Days
Class 2
Risk

K972244 is an FDA 510(k) clearance for the NT2000. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Laurel, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 256 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.

View all Bio-Medical Research, Ltd. devices

Submission Details

510(k) Number K972244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1997
Decision Date February 27, 1998
Days to Decision 256 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 148d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K972244.
ELECTRO-NERVE STIMULATOR TENS, MODEL LX
K990230 · Biomedical Life Systems, Inc. · Aug 1999
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999
INTELECT
K974497 · Chattanooga Group, Inc. · Jan 1998
EPIX VT
K970203 · Empi · Apr 1997
FOCUS MODEL 795 UNIT
K951951 · Empi · May 1996