Cleared Traditional

K905672 - TEAM-MC

K905672 is an FDA 510(k) clearance for TEAM-MC, manufactured by Henley Intl.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K905672 · Henley Intl. · Neurology device
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Oct 1991
Decision
301d
Days
Class 2
Risk

K905672 is an FDA 510(k) clearance for the TEAM-MC. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on October 15, 1991 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K905672

510(k) Number K905672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date October 15, 1991
Days to Decision 301 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
152d slower than avg
Panel avg: 149d · This submission: 301d
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 K905672.
Q-TENS
K912460 · Quantitative Medicine, Inc. · Nov 1991
MICRO-Q
K912463 · Quantitative Medicine, Inc. · Nov 1991
BIO TENS 601, 606 AND 608 (3000)
K912178 · Skylark Device Co., Ltd. · Oct 1991
AXION 5, MODIFICATION
K911814 · Ventura Medical Electronics · Oct 1991
MEDA CROWN SERIES
K913800 · Medical Electronic Assn. · Oct 1991
SOLITENS MODIFIED
K913522 · Innovative Designer Products, Inc. · Aug 1991
K905672 · TEAM-MC
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