Cleared Special

MODEL J-5 MVO-MONITOR

K031998 · Myotronics-Noromed, Inc. · Dental

Jul 2003

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K031998 is an FDA 510(k) clearance for the MODEL J-5 MVO-MONITOR, 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 24, 2003, 27 days after receiving the submission on June 27, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K031998 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2003
Decision Date	July 24, 2003
Days to Decision	27 days
Submission Type	Special
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.