Cleared Traditional

ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE

K901902 · Microcurrent Research, Inc. · Dental

Oct 1990

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K901902 is an FDA 510(k) clearance for the ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE, 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 October 9, 1990, 165 days after receiving the submission on April 27, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K901902 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 1990
Decision Date	October 09, 1990
Days to Decision	165 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.