Cleared Special

MODEL J-5 MVO-MONITOR (K031998) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031998 · Myotronics-Noromed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
27d
Days
Class 2
Risk

K031998 is an FDA 510(k) clearance for the MODEL J-5 MVO-MONITOR. Classified as Stimulator, Muscle, Powered, Dental (product code NUW), Class II - Special Controls.

Submitted by Myotronics-Noromed, Inc. (Tukwila, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 890.5850 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Myotronics-Noromed, Inc. devices

Submission Details

510(k) Number K031998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NUW Stimulator, Muscle, Powered, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
Definition Relief Of Muscle Spasms Associated With Tmj. Muscle Reeducation, Increasing Blood Flow.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.