Cleared Traditional

K061650 - SELECT TENS

K061650 is the FDA 510(k) clearance for SELECT TENS by Empi. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K061650 · Empi · Neurology device
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Jan 2007
Decision
223d
Days
Class 2
Risk

K061650 is an FDA 510(k) clearance for the SELECT TENS, MODEL 4600S. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Empi (St. Paul, US). The FDA issued a Cleared decision on January 22, 2007 after a review of 223 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 Empi devices

Submission Details

510(k) Number K061650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2006
Decision Date January 22, 2007
Days to Decision 223 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 148d · This submission: 223d
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 94
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K061650.
BioWaveGO
K180943 · Biowave Corporation · Aug 2018
TENS device-EmeTerm, CinvStop
K172478 · Wat Medical Technology (Ningbo) Co., Ltd. · Apr 2018
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi · Jun 2009
WINNER CM4 COMBINATION UNIT
K012848 · Rich-Mar Corp. · Oct 2001
VECTRA STIM MODELS 200 AND 400
K982321 · Chattanooga Group, Inc. · Feb 1999
VECTRA PRO MODELS 2 AND 4
K982324 · Chattanooga Group, Inc. · Feb 1999