Cleared Traditional

STIMPOD NMS450 Nerve Stimulator

K213049 · Xavant Technology (Pty), Ltd. · Anesthesiology
Oct 2022
Decision
389d
Days
Class 2
Risk

About This 510(k) Submission

K213049 is an FDA 510(k) clearance for the STIMPOD NMS450 Nerve Stimulator, a Stimulator, Nerve, Battery-powered (Class II — Special Controls, product code BXN), submitted by Xavant Technology (Pty), Ltd. (Pretoria, ZA). The FDA issued a Cleared decision on October 16, 2022, 389 days after receiving the submission on September 22, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K213049 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2021
Decision Date October 16, 2022
Days to Decision 389 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BXN — Stimulator, Nerve, Battery-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2775

Similar Devices — BXN Stimulator, Nerve, Battery-powered

All 62
MultiStim ECO
K162086 · PAJUNK GmbH Medizintechnologie · Jan 2017
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
K153045 · Easy Med Instrument Co., Ltd. · May 2016
MiniStim MS-IVB Peripheral Nerve Stimulator
K143095 · Halyard Health, Inc. · Mar 2015
STIMPOD ST2-3010 NERVE STIMULATOR
K140853 · Xavant Technology (Pty), Ltd. · Nov 2014
EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
K121743 · Sunmed, LLC · Mar 2013
MYOGUIDE SYSTEM MODEL 8008
K111985 · Intronix Technologies Corp. · Dec 2011