Cleared Traditional

VEINOPLUS Back

K251958 · Dynapulse Medical · Neurology

Dec 2025

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K251958 is an FDA 510(k) clearance for the VEINOPLUS Back, a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Dynapulse Medical (Minnetonka, US). The FDA issued a Cleared decision on December 23, 2025, 181 days after receiving the submission on June 25, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K251958 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 25, 2025
Decision Date	December 23, 2025
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles