Cleared Traditional

K902195 - TBD TENS REUSABLE ELECTRODE

K902195 is the FDA 510(k) clearance for TBD TENS REUSABLE ELECTRODE by Empi. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K902195 · Empi · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
23d
Days
Class 2
Risk

K902195 is an FDA 510(k) clearance for the TBD TENS REUSABLE ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Empi (Arden Hills, US). The FDA issued a Cleared decision on June 8, 1990 after a review of 23 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 Empi devices

Submission Details

510(k) Number K902195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date June 08, 1990
Days to Decision 23 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
125d faster than avg
Panel avg: 148d · This submission: 23d
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 139
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K902195.
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co. · Dec 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990
MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE
K901103 · Empi · Mar 1990
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989