Acusource 600 for Use with TMJ Electrode
FDA 510(k) K901902 · Microcurrent Research, Inc.
510(k) numberK901902
Submission
- Device name
- Acusource 600 for Use with TMJ Electrode
- Applicant
- Microcurrent Research, Inc.
New Haven, CT, US - Received
- April 27, 1990
- Decision date
- October 9, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NUW – Stimulator, Muscle, Powered, Dental
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
Relief of muscle spasms associated with tmj. Muscle reeducation, increasing blood flow.
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|---|---|---|---|
| K243290 | BTL-785MJNUW · Traditional | BTL Industries, Inc. | 05/09/2025SE |
| K203525 | D functionNUW · Traditional | Ito Co., Ltd. | 05/05/2021SE |
| K040400 | Myo-Trode SG Disposable ElectrodeNUW · Traditional | Myotronics-Noromed, Inc. | 07/20/2004SE |
| K031998 | Model J-5 Mvo-MonitorNUW · Special | Myotronics-Noromed, Inc. | 07/24/2003SE |
| K890143 | Acutron Multiwave for Use in TMJ Syndrome Pain ConNUW · Traditional | Microcurrent Research, Inc. | 05/01/1989SE |
| K842224 | BNS 40NUW · Traditional | Myo-Tronics Research, Inc. | 11/19/1984SE |
| K842223 | J4 Myo-MonitorNUW · Traditional | Myo-Tronics Research, Inc. | 11/19/1984SE |
| K770252 | Monitor, Myo, Model J3NUW · Traditional | Myo-Tronics Research, Inc. | 02/18/1977SE |
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Questions and answers
When was Acusource 600 for Use with TMJ Electrode cleared by the FDA?
Acusource 600 for Use with TMJ Electrode (K901902) received a 510(k) decision of Substantially Equivalent on October 9, 1990, 165 days after the submission was received.
What is the product code of K901902?
The FDA product code is NUW – Stimulator, Muscle, Powered, Dental, a Class II (moderate risk) device regulated under 21 CFR 890.5850.