Cleared Traditional

K832238 - NEUROMOD COMFORT WAVE #7721 DUAL-

K832238 is an FDA 510(k) clearance for NEUROMOD COMFORT WAVE #7721 DUAL-, 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 51-day FDA review.

K832238 · Medtronic Vascular · Neurology device
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Aug 1983
Decision
51d
Days
Class 2
Risk

K832238 is an FDA 510(k) clearance for the NEUROMOD COMFORT WAVE #7721 DUAL-. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 51 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 - K832238

510(k) Number K832238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date August 31, 1983
Days to Decision 51 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 149d · This submission: 51d
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 602
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K832238.
ELECTRO-ACUSCOPE
K832442 · Kenneth J. Purcell · Oct 1983
ELECTRONEURAL STIMULATOR 12
K831487 · Meridia 12 Corp. · Oct 1983
AGAR 8000 TENS
K832851 · Kimed Industries, Inc. · Oct 1983
AUTO-TENS MODEL V
K832337 · Cbc Corp. · Aug 1983
XCEL MODEL XE-1
K830992 · Electrocaine Medical System · Aug 1983
PULSAR #B SINGLE CHANNEL TENS-PULSAR D
K831950 · Spembly Medical , Ltd. · Aug 1983
K832238 · NEUROMOD COMFORT WAVE #7721 DUAL-
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