510(k) K842224
- Device
- BNS 40
- Applicant
- MYO-TRONICS RESEARCH, INC.
- 510(k) number
- K842224
- Product code
- NUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-19
- Date received
- 1984-06-05
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered, Dental
- Medical specialty
- Physical Medicine
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRAY ADIB
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9614750
- 9613446
- 3014732
- 3035374386
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NUW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243290 | BTL-785MJ | BTL Industries, Inc. | 2025-05-09 |
| K203525 | D function | Ito Co., Ltd. | 2021-05-05 |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | Myotronics-Noromed, Inc. | 2004-07-20 |
| K031998 | MODEL J-5 MVO-MONITOR | Myotronics-Noromed, Inc. | 2003-07-24 |
| K901902 | ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE | Microcurrent Research, Inc. | 1990-10-09 |
| K890143 | ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON | Microcurrent Research, Inc. | 1989-05-01 |
| K842223 | J4 MYO-MONITOR | Myo-Tronics Research, Inc. | 1984-11-19 |
| K770252 | MONITOR, MYO, MODEL J3 | Myo-Tronics Research, Inc. | 1977-02-18 |
Legacy Summary#
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FDA Review#
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