Cleared Traditional

K884814 - BIOTENS

K884814 is an FDA 510(k) clearance for BIOTENS, manufactured by Trekk Intl.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K884814 · Trekk Intl. · Neurology device
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Feb 1989
Decision
102d
Days
Class 2
Risk

K884814 is an FDA 510(k) clearance for the BIOTENS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Trekk Intl. (Sausalito, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trekk Intl. devices

FDA 510(k) Submission Details - K884814

510(k) Number K884814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date February 27, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 148d · This submission: 102d
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 318
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K884814.
EMPI ISLAND TENS ELECTRODE
K890605 · Empi · Mar 1989
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890614 · Empi · Mar 1989
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890747 · Empi · Mar 1989
MODIFIED JELTRODE(TM) ELECTRODES DEEMED
K884348 · Henley Intl. · Dec 1988
MULTIDAY, MODELS 8300 AND 8310
K882888 · Medical Devices, Inc. · Sep 1988
PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535
K882886 · Medical Devices, Inc. · Sep 1988