Cleared Traditional

K082011 - MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458

K082011 is an FDA 510(k) clearance for MEDISTIM XP, manufactured by Bio-Medical Research, Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K082011 · Bio-Medical Research, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
136d
Days
Class 2
Risk

K082011 is an FDA 510(k) clearance for the MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Bio-Medical Research, Ltd. (Galway, IE). The FDA issued a Cleared decision on November 28, 2008 after a review of 136 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.

FDA 510(k) Submission Details - K082011

510(k) Number K082011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2008
Decision Date November 28, 2008
Days to Decision 136 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
13d faster than avg
Panel avg: 149d · This submission: 136d
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 597
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K082011.
TENS-EMS-14
K083030 · Emsi · Feb 2009
ULTIMA FIVE
K083494 · Pain Management Technologies · Jan 2009
COMBOCARE 2000
K083202 · Xanacare Technologies, LLC · Dec 2008
TENS/EMS COMBO, EMS, TENS
K082514 · Medihightec Medical Co., Ltd. · Oct 2008
EA STIMULATOR
K080221 · Helio Medical Supplies, Inc. · Sep 2008
COMBOCARE 2000
K081141 · Xanacare Technologies, LLC · Aug 2008
K082011 · MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458
Download PDF FDA Summary Bio-Medical Research,…