Cleared Traditional

MYO-TRODE SG DISPOSABLE ELECTRODE

K040400 · Myotronics-Noromed, Inc. · Dental

Jul 2004

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K040400 is an FDA 510(k) clearance for the MYO-TRODE SG DISPOSABLE ELECTRODE, a Stimulator, Muscle, Powered, Dental (Class II — Special Controls, product code NUW), submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on July 20, 2004, 154 days after receiving the submission on February 17, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K040400 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2004
Decision Date	July 20, 2004
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NUW — Stimulator, Muscle, Powered, Dental
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.