ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
FDA 510(k) clearance K901902 · decided 1990-10-09
Clearance details
- K-number
- K901902
- Device name
- ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
- Applicant
- Microcurrent Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-27
- Decision date
- 1990-10-09
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- NUW
- Device class
- 2
- Regulation number
- 890.5850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- New Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BTL-785MJ (K243290) | BTL Industries, Inc. | 2025-05-09 |
| D function (K203525) | Ito Co., Ltd. | 2021-05-05 |
| MYO-TRODE SG DISPOSABLE ELECTRODE (K040400) | Myotronics-Noromed, Inc. | 2004-07-20 |
| MODEL J-5 MVO-MONITOR (K031998) | Myotronics-Noromed, Inc. | 2003-07-24 |
| ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON (K890143) | Microcurrent Research, Inc. | 1989-05-01 |
| BNS 40 (K842224) | Myo-Tronics Research, Inc. | 1984-11-19 |
| J4 MYO-MONITOR (K842223) | Myo-Tronics Research, Inc. | 1984-11-19 |
| MONITOR, MYO, MODEL J3 (K770252) | Myo-Tronics Research, Inc. | 1977-02-18 |
Recalls involving this device
No recalls on record reference this clearance.