Cleared Traditional

K083250 - NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS

K083250 is an FDA 510(k) clearance for NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS, manufactured by Aa Neuromed Corp.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K083250 · Aa Neuromed Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
287d
Days
Class 2
Risk

K083250 is an FDA 510(k) clearance for the NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Aa Neuromed Corp. (Port Coquitlam, Bc, CA). The FDA issued a Cleared decision on August 18, 2009 after a review of 287 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.

FDA 510(k) Submission Details - K083250

510(k) Number K083250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2008
Decision Date August 18, 2009
Days to Decision 287 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
138d slower than avg
Panel avg: 149d · This submission: 287d
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 451
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K083250.
SMART TENS, MODEL: D-BC05T
K091045 · Body Clock Health Care, Ltd. · Dec 2009
AMD 6605 TENS/NMES
K092990 · Advantageous Medical Devices, LLC · Oct 2009
NEUROCALM MODEL 1 AND 2
K090866 · Neuromed Devices, Inc. · Oct 2009
MANTRA COMBO, MODEL MECS 320
K091236 · Mantra Intl. (Hk) , Ltd. · Jul 2009
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK
K091317 · Bio-Medical Research, Ltd. · Jun 2009
EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR
K090922 · Empi · Jun 2009
K083250 · NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
Download PDF FDA Summary Aa Neuromed Corp.