M-Scan
by Bio-Research Associates, Inc.
510(k) K130158
M-Scan is a medical device (FDA Class II; FDA product code KZM, Device, Muscle Monitoring) made by Bio-Research Associates, Inc., cleared under FDA 510(k) K130158 on 25 Jul 2013, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130158 | Date25 Jul 2013 | StatusActive |
Official records
- FDA 510(k) database K130158
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KZM
- Device class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130158
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| M-Scan Clench | Clench | 00860003499962 | — | On the market |
| M-Scan Rest | Rest | 00860003499955 | — | On the market |
Similar devices
Other devices filed under FDA product code KZM (Device, Muscle Monitoring).
- K6-I Diagnostic System by Myo-Tronics, Inc.
- Dolotens Dental 1 by Neuromuscular Technologies, Inc.
- GRINDCARE MEASURE by Medotech A/S
- DENTAL ANESTHESIA APPARATUS by Pain Prevention, Inc.
- MODEL K7 EVALUATION DEVICE by MYOTRONICS-NOROMED, INC.
- Nox C1 Kit NOX-C1KIT1 544020 by Nox Medical
- Nox A1s System NOX-A1S_USF 513113 by Nox Medical
- MS-100 MYO-SCANNER OR MS-100 EMG SCANNER by Myo-Tronics, Inc.
- COMFORTRON by M. D. Supply, Inc.
- E.W.L. P-TENS/H-WAVE by Electronic Waveform Laboratory, Inc.