NUW — Stimulator, Muscle, Powered, Dental Class II

FDA Device Classification

Classification Details

Product Code
NUW
Device Class
Class II
Regulation Number
890.5850
Submission Type
Review Panel
DE
Medical Specialty
Physical Medicine
Implant
No

Definition

Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243290btl industriesBTL-785MJMay 9, 2025
K203525ito coD functionMay 5, 2021
K040400myotronics-noromedMYO-TRODE SG DISPOSABLE ELECTRODEJuly 20, 2004
K031998myotronics-noromedMODEL J-5 MVO-MONITORJuly 24, 2003
K901902microcurrent researchACUSOURCE 600 FOR USE WITH TMJ ELECTRODEOctober 9, 1990
K890143microcurrent researchACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CONMay 1, 1989
K842223myo-tronics researchJ4 MYO-MONITORNovember 19, 1984
K842224myo-tronics researchBNS 40November 19, 1984
K770252myo-tronics researchMONITOR, MYO, MODEL J3February 18, 1977