Stimulator, Muscle, Powered, Dental
The Powered Dental Muscle Stimulator is an electrically powered device used for the relief of muscle spasms associated with temporomandibular joint (TMJ) disorders, as well as for muscle reeducation and increasing local blood flow in the dental and craniofacial region. It is an FDA Class 2 device regulated under 21 CFR 890.5850 in the Physical Medicine specialty, reviewed by the Dental panel, with product code NUW, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUW
- Device Class
- FDA class 2
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Definition
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243290 | BTL-785MJ | May 09, 2025 | Substantially Equivalent | BTL Industries, Inc. |
| K203525 | D function | May 05, 2021 | Substantially Equivalent | Ito Co., Ltd. |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Jul 20, 2004 | Substantially Equivalent | Myotronics-Noromed, Inc. |
| K031998 | MODEL J-5 MVO-MONITOR | Jul 24, 2003 | Substantially Equivalent | Myotronics-Noromed, Inc. |
| K901902 | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Oct 09, 1990 | Substantially Equivalent | Microcurrent Research, Inc. |
| K890143 | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | May 01, 1989 | Substantially Equivalent | Microcurrent Research, Inc. |
| K842224 | BNS 40 | Nov 19, 1984 | Substantially Equivalent | Myo-Tronics Research, Inc. |
| K842223 | J4 MYO-MONITOR | Nov 19, 1984 | Substantially Equivalent | Myo-Tronics Research, Inc. |
| K770252 | MONITOR, MYO, MODEL J3 | Feb 18, 1977 | Substantially Equivalent | Myo-Tronics Research, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.