Cleared Traditional

K911963 - MEDTRONIC MODEL 90002065 MF TENS SYSTEM

K911963 is an FDA 510(k) clearance for MEDTRONIC MODEL 90002065 MF TENS SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K911963 · Medtronic Vascular · Neurology device
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Dec 1991
Decision
222d
Days
Class 2
Risk

K911963 is an FDA 510(k) clearance for the MEDTRONIC MODEL 90002065 MF TENS SYSTEM. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 10, 1991 after a review of 222 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 - K911963

510(k) Number K911963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1991
Decision Date December 10, 1991
Days to Decision 222 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 149d · This submission: 222d
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 604
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K911963.
THERASTIM
K914813 · Precision Electronics , Ltd. · Dec 1991
TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL
K914871 · Labeltape Meditect, Inc. · Dec 1991
MENS 2000-D
K914441 · Monad Corp. · Dec 1991
ULTIMA XS, MODIFICATION
K912289 · American Imex · Nov 1991
TX 3 TENS MODIFIED
K913532 · Globalcare/Bay Medical Corp. · Nov 1991
RELIEF BAND (T.E.N.S. DEVICE)
K901704 · Maven Labs, Inc. · Nov 1991
K911963 · MEDTRONIC MODEL 90002065 MF TENS SYSTEM
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