Cleared Traditional

K822224 - EMPI SINGLE USE

K822224 is an FDA 510(k) clearance for EMPI SINGLE USE, manufactured by Empi. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K822224 · Empi · Neurology device
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Aug 1982
Decision
20d
Days
Class 2
Risk

K822224 is an FDA 510(k) clearance for the EMPI SINGLE USE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Empi (Walker, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 20 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.

FDA 510(k) Submission Details - K822224

510(k) Number K822224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1982
Decision Date August 16, 1982
Days to Decision 20 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
129d faster than avg
Panel avg: 149d · This submission: 20d
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 413
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K822224.
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K830602 · Precision Cap Systems · Mar 1983
TENS ELECTRODE
K822378 · Franklin Sales & Mfg. Co. · Aug 1982
MODEL 3854 ELECTRODE
K820876 · Medtronic Vascular · Apr 1982
POST-OP ELECTRODE (TENS ELECTRODE)
K820082 · Consolidated Medical Equipment, Inc. · Jan 1982
MEDTRONIC #3798 ELECTRODE
K812418 · Medtronic Vascular · Sep 1981
K822224 · EMPI SINGLE USE
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