Cleared Traditional

K973979 - MULTI-STIM TENS, AP-101081T

K973979 is an FDA 510(k) clearance for MULTI-STIM TENS, manufactured by Apex Medical Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K973979 · Apex Medical Corp. · Neurology device
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Jul 1998
Decision
282d
Days
Class 2
Risk

K973979 is an FDA 510(k) clearance for the MULTI-STIM TENS, AP-101081T. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on July 29, 1998 after a review of 282 days - an extended review 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: 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 Apex Medical Corp. devices

FDA 510(k) Submission Details - K973979

510(k) Number K973979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1997
Decision Date July 29, 1998
Days to Decision 282 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
134d slower than avg
Panel avg: 148d · This submission: 282d
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 286
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K973979.
PREMIER AP
K982221 · American Imex · Sep 1998
GB-1002 TENS WITH MASSAGE
K964437 · Skylark Device Co., Ltd. · Aug 1998
MICRO II MICROCURRENT TENS
K973978 · Apex Medical Corp. · Jul 1998
ACU-STIM TENS, AP-101082T
K973980 · Apex Medical Corp. · Jul 1998
NT2000
K972244 · Bio-Medical Research, Ltd. · Feb 1998
RELIEFBAND
K980333 · Woodside Biomedical, Inc. · Feb 1998