D function
D function is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K203525 on 5 May 2021 and listed in FDA GUDID since 9 Sep 2021 (UDI-DI 04983087012394), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04983087012394 | Date9 Sep 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203525 | Date5 May 2021 | StatusActive |
Official records
- AccessGUDID record 04983087012394
- FDA 510(k) database K203525
Across registries
- FDA 510(k) K203525 decided 5 May 2021 Active
- FDA GUDID UDI-DI 04983087012394 listed 9 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K203525
- Listed FDA GUDID 04983087012394
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Mastication muscle electrical stimulation system
- Model / reference
- D function
- Primary DI / UDI-DI
- 04983087012394
- 510(k) Number
- FDA product code
- NUW
- GMDN term
- Mastication muscle electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NUW (Stimulator, Muscle, Powered, Dental).
- MODEL J-5 MVO-MONITOR by MYOTRONICS-NOROMED, INC.
- BNS 40 by Myo-Tronics Research, Inc.
- MONITOR, MYO, MODEL J3 by Myo-Tronics Research, Inc.
- ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON by Microcurrent Research, Inc.
- MYO-TRODE SG DISPOSABLE ELECTRODE by MYOTRONICS-NOROMED, INC.
- BTL-785MJ by BTL Industries, Inc.
- ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE by Microcurrent Research, Inc.