Cleared Traditional

K233364 - Axon Therapy

K233364 is an FDA 510(k) clearance for Axon Therapy, manufactured by Neuralace Medical, Inc.. The device is a Class 2 Physical Medicine device with product code QPL cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K233364 · Neuralace Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
100d
Days
Class 2
Risk

K233364 is an FDA 510(k) clearance for the Axon Therapy. Classified as Electromagnetic Stimulator, Pain Relief (product code QPL), Class II - Special Controls.

Submitted by Neuralace Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on January 10, 2024 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Neuralace Medical, Inc. devices

FDA 510(k) Submission Details - K233364

510(k) Number K233364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2023
Decision Date January 10, 2024
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

QPL Device Classification - Class 2, Special Controls

Product Code QPL Electromagnetic Stimulator, Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

RQM+
Allison Komiyama

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.

Clinical Evidence

ClinicalTrials.gov
NCT05620225 Completed Interventional Industry-sponsored

Axon Therapy and Conventional Medical Management for Painful Diabetic Neuropathy Compared to Sham and Conventional Medical Management

A Multicenter, Randomized, Clinical Trial Comparing the Safety and Effectiveness of Axon Therapy and Conventional Medical Management (AT+CMM) for the Treatment of Painful Diabetic Neuropathy to Sham and Conventional Medical Management (Sham+CMM)

93
Patients (actual)
7
Sites
Treatment
Purpose
Triple
Masking
Condition studied Neuralgia; Neuropathic Pain; Painful Diabetic Neuropathy
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Joe Milkovits
Sponsor NeuraLace Medical, Inc. (industry)
Started 2022-12-15 → Primary completion 2023-08-23 → Completed 2023-11-22
Primary outcome
Comparison of the Proportion of Responders
Secondary outcome
Visual Analog Scale (VAS) for Pain
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - QPL Electromagnetic Stimulator, Pain Relief

Devices cleared under the same product code (QPL) and FDA review panel - the closest regulatory comparables to K233364.
BTL-199
K250309 · BTL Industries, Inc. · Aug 2025
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
K250286 · The Magstim Company Limited · Jul 2025
StarFormer (M008-3T)
K241785 · Fotona D.O.O. · Mar 2025
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
K230014 · Tonica Elektronik A/S · Aug 2023
Axon Therapy
K210021 · Neuralace Medical, Inc. · Jun 2021