Cleared Traditional

Axon Therapy

K233364 · Neuralace Medical, Inc. · Physical Medicine

Jan 2024

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K233364 is an FDA 510(k) clearance for the Axon Therapy, a Electromagnetic Stimulator, Pain Relief (Class II — Special Controls, product code QPL), submitted by Neuralace Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on January 10, 2024, 100 days after receiving the submission on October 2, 2023. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K233364 FDA.gov
FDA Decision	Cleared 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

Device Classification

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