DeviceClearance

Product code NUW— Physical Medicine

ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE

Classification name
Stimulator, Muscle, Powered, Dental
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Total cleared
9
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code NUW under 21 CFR 890.5850, via openFDA

Market context for product code NUW

FDA has cleared 9 devices under product code NUW between 1977 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NUW

Recent clearances under product code NUW

Data sourced from openFDA. This site is unofficial and independent of the FDA.