Cleared Traditional

K083030 - TENS-EMS-14

K083030 is an FDA 510(k) clearance for TENS-EMS-14, manufactured by Emsi. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K083030 · Emsi · Neurology device
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Feb 2009
Decision
118d
Days
Class 2
Risk

K083030 is an FDA 510(k) clearance for the TENS-EMS-14. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Emsi (Alexandria, US). The FDA issued a Cleared decision on February 5, 2009 after a review of 118 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 Emsi devices

FDA 510(k) Submission Details - K083030

510(k) Number K083030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2008
Decision Date February 05, 2009
Days to Decision 118 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 167
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K083030.
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
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DX6605E-TENS, DX6605E-G, DX6609-G
K082057 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2009
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd. · Nov 2008
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited · Jun 2008
COMFY SERIES: EV-804, EV-805 & EV-806
K071951 · Everyway Medical Instruments Co.,Ltd · Sep 2007