Cleared Traditional

K233364 - Axon Therapy (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence.

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

Submission Details

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.

Device Classification

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