Cleared Traditional

K901575 - REUSABLE TENS PARAVERTEBRAL PAD #641 BA...

K901575 is the FDA 510(k) clearance for REUSABLE TENS PARAVERTEBRAL PAD #641 BA... by Pioneering Technologies, Inc.. It is a Class 2 Neurology device (product code GXY) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K901575 · Pioneering Technologies, Inc. · Neurology device
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May 1990
Decision
29d
Days
Class 2
Risk

K901575 is an FDA 510(k) clearance for the REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wabasha, US). The FDA issued a Cleared decision on May 2, 1990 after a review of 29 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 Pioneering Technologies, Inc. devices

Submission Details

510(k) Number K901575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date May 02, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 148d · This submission: 29d
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 144
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K901575.
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
VERSA-STIM ELECTRODE LINE MODIFIED
K911069 · Conmedcorp · Jul 1991
TBD TENS REUSABLE ELECTRODE
K902195 · Empi · Jun 1990
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