Cleared Traditional

K881424 - PREMIER 10S (TENS)

K881424 is an FDA 510(k) clearance for PREMIER 10S (TENS), manufactured by American Imex. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K881424 · American Imex · Neurology device
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Apr 1988
Decision
6d
Days
Class 2
Risk

K881424 is an FDA 510(k) clearance for the PREMIER 10S (TENS). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by American Imex (Irvine, US). The FDA issued a Cleared decision on April 11, 1988 after a review of 6 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 - K881424

510(k) Number K881424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date April 11, 1988
Days to Decision 6 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
143d faster than avg
Panel avg: 149d · This submission: 6d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K881424.
INTERCEPT T.E.N.S. DEVICE
K880492 · Medical Design & Manufacturing Corp. · Apr 1988
EMPI MODEL 989, TENS
K881114 · Empi · Apr 1988
SCHULDT* PC* - DUAL CHANNEL TENS
K880980 · Schuldt Laboratories, Inc. · Apr 1988
ULTIMA XS (TENS)
K880751 · American Imex · Apr 1988
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
K880452 · Lumiscope Co., Inc. · Mar 1988
AMASTIM 2000
K872704 · Amatech International, Inc. · Jan 1988
K881424 · PREMIER 10S (TENS)
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