510(k) K243290
- Device
- BTL-785MJ
- Applicant
- BTL Industries, Inc.
- 510(k) number
- K243290
- Product code
- NUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-09
- Date received
- 2024-10-18
- Regulation
- 890.5850
- Classification name
- Stimulator, Muscle, Powered, Dental
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Chmel
- Address
- 362 Elm St. Marlborough MA US 01752 01752
FDA Registration Numbers#
- 3035374386
- 9614750
- 9613446
- 3014732
Source Documents#
Other 510(k) Records For Product Code NUW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K842224 | BNS 40 | Myo-Tronics Research, Inc. | 1984-11-19 |
| K770252 | MONITOR, MYO, MODEL J3 | Myo-Tronics Research, Inc. | 1977-02-18 |