510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NUWClass II

Stimulator, Muscle, Powered, Dental

21 CFR 890.5850 / Physical Medicine
FDA source (opens on fda.gov)

NUW is the FDA product code for Stimulator, Muscle, Powered, Dental, a class II device type, regulated under 21 CFR 890.5850. FDA's definition for this code reads: "Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NUW
Device name
Stimulator, Muscle, Powered, Dental
FDA definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
Regulation
21 CFR 890.5850
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
0

Clearances, product code NUW

By decision year
9 clearances under product code NUW with a decision year between 1977 and 2025, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NUW by decision year
YearClearances
19771
19842
19891
19901
20031
20041
20211
20251

Applicants with the most clearances

Product code NUW
Applicants holding the most 510(k) clearances under product code NUW
ApplicantClearances
Myo-Tronics Research, Inc.3
Microcurrent Research, Inc.2
Myotronics-Noromed, Inc.2
BTL Industries, Inc1
Ito Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code