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NUW

Stimulator, Muscle, Powered, Dental

Product code
NUW
Device name
Stimulator, Muscle, Powered, Dental
Device class
Class 2
21 CFR
21 CFR 890.5850
Medical specialty
Physical Medicine
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-05-09.

NumberDecision dateApplicantDevice nameSummary
K2432902025-05-09BTL Industries, Inc.BTL-785MJPDF

1 summaries are archived here for direct download.

Official FDA classification page: NUW
Classification and pathway per current FDA publications. Data from openFDA (CC0).