Cleared Traditional

K874469 - TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)

K874469 is an FDA 510(k) clearance for TRANSCUTANEOUS ELECTRIC NERVE STIMULATI..., manufactured by Axelgaard Mfg. Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K874469 · Axelgaard Mfg. Co., Ltd. · Neurology device
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Jan 1988
Decision
87d
Days
Class 2
Risk

K874469 is an FDA 510(k) clearance for the TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS). Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Fallbrook, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

View all Axelgaard Mfg. Co., Ltd. devices

FDA 510(k) Submission Details - K874469

510(k) Number K874469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date January 28, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 301
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K874469.
SPARE MS 700 TENS ELECTRODE
K881871 · Lectec Corp. · Jun 1988
TENS ELECTRODE MODEL 238P
K881872 · Lectec Corp. · Jun 1988
TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K880649 · Labeltape Meditect, Inc. · Mar 1988
MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
K875284 · Medtronic Vascular · Jan 1988
LECTEC STIMULATING ELECTRODE
K872250 · Lectec Corp. · Aug 1987
TENSAGAIN
K872574 · Ferris Mfg. Corp. · Jul 1987