Cleared Traditional

K092990 - AMD 6605 TENS/NMES

K092990 is an FDA 510(k) clearance for AMD 6605 TENS/NMES, manufactured by Advantageous Medical Devices, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K092990 · Advantageous Medical Devices, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
25d
Days
Class 2
Risk

K092990 is an FDA 510(k) clearance for the AMD 6605 TENS/NMES. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Advantageous Medical Devices, LLC (Virginia Beach, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 25 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 - K092990

510(k) Number K092990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date October 23, 2009
Days to Decision 25 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
124d faster than avg
Panel avg: 149d · This submission: 25d
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.
JEFF D RONGERO

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 K092990.
SCENAR, MODEL 10
K092117 · Ritm Okb Zao · May 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · Hivox Biotek, Inc. · Mar 2010
SMART TENS, MODEL: D-BC05T
K091045 · Body Clock Health Care, Ltd. · Dec 2009
NEUROCALM MODEL 1 AND 2
K090866 · Neuromed Devices, Inc. · Oct 2009
NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
K083250 · Aa Neuromed Corp. · Aug 2009
MANTRA COMBO, MODEL MECS 320
K091236 · Mantra Intl. (Hk) , Ltd. · Jul 2009
K092990 · AMD 6605 TENS/NMES
Download PDF FDA Summary Advantageous Medical …