Cleared Traditional

K982221 - PREMIER AP

K982221 is an FDA 510(k) clearance for PREMIER AP, 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 90-day FDA review.

K982221 · American Imex · Neurology device
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Sep 1998
Decision
90d
Days
Class 2
Risk

K982221 is an FDA 510(k) clearance for the PREMIER AP. 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 September 22, 1998 after a review of 90 days - within the typical 510(k) review window.

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: 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 American Imex devices

FDA 510(k) Submission Details - K982221

510(k) Number K982221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date September 22, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 276
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K982221.
ACUTRON MENTOR MODEL 961
K981976 · Microcurrent Research, Inc. · Nov 1998
SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE
K982410 · Rehabilicare, Inc. · Nov 1998
RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
K982436 · Woodside Biomedical, Inc. · Oct 1998
GB-1002 TENS WITH MASSAGE
K964437 · Skylark Device Co., Ltd. · Aug 1998
MICRO II MICROCURRENT TENS
K973978 · Apex Medical Corp. · Jul 1998
MULTI-STIM TENS, AP-101081T
K973979 · Apex Medical Corp. · Jul 1998