Cleared Traditional

K852267 - ELECTRICAL NERVE STIMULATION(TENS) ELEC...

K852267 is the FDA 510(k) clearance for ELECTRICAL NERVE STIMULATION(TENS) ELEC... by Axelgaard Mfg. Co., Ltd.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K852267 · Axelgaard Mfg. Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
21d
Days
Class 2
Risk

K852267 is an FDA 510(k) clearance for the ELECTRICAL NERVE STIMULATION(TENS) ELECTRODES. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Axelgaard Mfg. Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on June 18, 1985 after a review of 21 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

Submission Details

510(k) Number K852267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1985
Decision Date June 18, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 147
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K852267.
JELTRODE
K861956 · Henley Intl. · Jun 1986
EMPI, NMS/SUE CUTANEOUS ELECTRODE
K854513 · Empi · Dec 1985
TRANSCUTANEOUS ELECTRICAL NERVE STIMULA-ELECTORDE
K851175 · Medical Devices, Inc. · Jun 1985
COMFORT-EASE ELECTRODE
K851303 · Medtronic Vascular · May 1985
CANMED 103
K844098 · Medtronic Vascular · Feb 1985
CANMED 103 9300 ELECTRODE
K844097 · Medtronic Vascular · Dec 1984