Cleared Traditional

ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON

K890143 · Microcurrent Research, Inc. · Dental

May 1989

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K890143 is an FDA 510(k) clearance for the ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON, a Stimulator, Muscle, Powered, Dental (Class II — Special Controls, product code NUW), submitted by Microcurrent Research, Inc. (New Haven, US). The FDA issued a Cleared decision on May 1, 1989, 108 days after receiving the submission on January 13, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K890143 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1989
Decision Date	May 01, 1989
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—

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.