D function
FDA 510(k) K203525 · Ito Co., Ltd.
510(k) numberK203525
Submission
- Device name
- D function
- Applicant
- Ito Co., Ltd.
Kawaguchi-Shi, JP - Received
- December 1, 2020
- Decision date
- May 5, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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.
Other 510(k)s with product code NUW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243290 | BTL-785MJNUW · Traditional | BTL Industries, Inc. | 05/09/2025SE |
| 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 |
| K901902 | Acusource 600 for Use with TMJ ElectrodeNUW · Traditional | Microcurrent Research, Inc. | 10/09/1990SE |
| 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 |
More from Myo-Tronics Research, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112520 | US-101L, US-103SIMI · Traditional | 10/26/2011SE |
| K081943 | Model ES-130BWK · Traditional | 11/24/2008SE |
| K081247 | TM-400ITH · Traditional | 08/25/2008SE |
| K032793 | US-100 Portable Ultrasound Therapy UnitIMI · Traditional | 10/09/2003SE |
| K022846 | SW-180 Shortwave Therapy UnitIMJ · Traditional | 01/28/2003SE |
| K990787 | Trio 300IPF · Traditional | 10/20/1999SE |
| K992545 | TM-300 Traction SystemITH · Traditional | 09/01/1999SE |
Questions and answers
When was D function cleared by the FDA?
D function (K203525) received a 510(k) decision of Substantially Equivalent on May 5, 2021, 155 days after the submission was received.
What is the product code of K203525?
The FDA product code is NUW – Stimulator, Muscle, Powered, Dental, a Class II (moderate risk) device regulated under 21 CFR 890.5850.