Cleared Traditional

K921828 - TEAM-MC II

K921828 is the FDA 510(k) clearance for TEAM-MC II by Henley Intl.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K921828 · Henley Intl. · Neurology device
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Sep 1992
Decision
159d
Days
Class 2
Risk

K921828 is an FDA 510(k) clearance for the TEAM-MC II. 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 September 22, 1992 after a review of 159 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 Henley Intl. devices

Submission Details

510(k) Number K921828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1992
Decision Date September 22, 1992
Days to Decision 159 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
11d slower than avg
Panel avg: 148d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K921828.
FLEXMATE
K934619 · Medical Devices, Inc. · Feb 1994
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INTELECT 600MP
K920260 · Chattanooga Group, Inc. · Oct 1992
ELECTRO-NERVE STIMULATOR TENS MODEL MICRO PLUS-A
K915210 · Biomedical Life Systems, Inc. · May 1992
MEDTRONIC MODEL 90002065 MF TENS SYSTEM
K911963 · Medtronic Vascular · Dec 1991
TEAM-MC
K905672 · Henley Intl. · Oct 1991