Cleared Traditional

K082514 - TENS/EMS COMBO, EMS, TENS

K082514 is an FDA 510(k) clearance for TENS/EMS COMBO, manufactured by Medihightec Medical Co., Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K082514 · Medihightec Medical Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
49d
Days
Class 2
Risk

K082514 is an FDA 510(k) clearance for the TENS/EMS COMBO, EMS, TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medihightec Medical Co., Ltd. (Keelung City, TW). The FDA issued a Cleared decision on October 21, 2008 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K082514

510(k) Number K082514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date October 21, 2008
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 149d · This submission: 49d
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 Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 451
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K082514.
ULTIMA FIVE
K083494 · Pain Management Technologies · Jan 2009
COMBOCARE 2000
K083202 · Xanacare Technologies, LLC · Dec 2008
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
K082011 · Bio-Medical Research, Ltd. · Nov 2008
EA STIMULATOR
K080221 · Helio Medical Supplies, Inc. · Sep 2008
COMBOCARE 2000
K081141 · Xanacare Technologies, LLC · Aug 2008
PRO TENS, MODEL WL-240 RX
K080304 · Well-Life Healthcare Limited · Jun 2008
K082514 · TENS/EMS COMBO, EMS, TENS
Download PDF FDA Summary Medihightec Medical C…