Cleared Traditional

K900656 - SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.

K900656 is an FDA 510(k) clearance for SPEC T.E.N.S. PREWIRED REPOSITIONABLE T..., manufactured by Labeltape Meditect, Inc.. 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.

K900656 · Labeltape Meditect, Inc. · Neurology device
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Mar 1990
Decision
20d
Days
Class 2
Risk

K900656 is an FDA 510(k) clearance for the SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Labeltape Meditect, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on March 1, 1990 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.

View all Labeltape Meditect, Inc. devices

FDA 510(k) Submission Details - K900656

510(k) Number K900656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date March 01, 1990
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
128d faster than avg
Panel avg: 148d · 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 297
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K900656.
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990
MODIFIED ISLAND SNAP TENS DISPOSABLE ELECTRODE
K901103 · Empi · Mar 1990
K-STERILE TENS ELECTRODES
K900997 · Katecho, Inc. · Mar 1990
BABE-EASE NEONATAL CLOTH ECG ELECTRODE
K896844 · Labeltape Meditect, Inc. · Feb 1990
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896936 · Labeltape Meditect, Inc. · Jan 1990
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989