KZM · Device, Muscle Monitoring
Physical Medicine · 21 CFR 890.1375 · Class 2
Overview
| Product Code | KZM |
|---|---|
| Device Name | Device, Muscle Monitoring |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161716 | TEETHAN 2.0 | Bts S.P.A. | Dec 21, 2016 | SESE |
| K130158 | M-SCAN | Bio-Research Associates, Inc. | Jul 25, 2013 | SESE |
| K113677 | GRINDCARE MEASURE | Medotech A/S | Apr 5, 2012 | SESE |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | Feb 6, 2009 | SESE |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | Sep 2, 2005 | SESE |
| K030869 | BITESTRIP | S.L.P. , Ltd. | May 14, 2004 | SESE |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | Jan 4, 2001 | SESE |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | Nov 6, 2000 | SESE |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | Sep 10, 1999 | SESE |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Bio-Research Associates, Inc. | Sep 15, 1998 | SESE |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | Dec 9, 1994 | SESE |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | Jun 9, 1994 | SN |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | Jan 7, 1993 | SESE |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | Apr 27, 1988 | SESE |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | Jun 17, 1987 | SESE |
| K862092 | COMFORTRON | M. D. Supply, Inc. | Oct 15, 1986 | SESE |
| K850425 | DENTAL ANESTHESIA APPARATUS | Pain Prevention, Inc. | Oct 9, 1986 | SN |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | Feb 9, 1983 | SESE |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | Mar 31, 1981 | SESE |
Top Applicants
- Bio-Research Associates, Inc. — 5 clearances
- Myo-Tronics, Inc. — 3 clearances
- Myo-Tronics Research, Inc. — 2 clearances
- Myotronics-Noromed, Inc. — 2 clearances
- Bts S.P.A. — 1 clearance
