KZM — Device, Muscle Monitoring Class II
FDA product code KZM covers "Device, Muscle Monitoring", a Class II medical device regulated under 21 CFR 890.1375. Submissions are reviewed by the Physical Medicine panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KZM
- Device Class
- Class II
- Regulation Number
- 890.1375
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161716 | bts | TEETHAN 2.0 | December 21, 2016 |
| K130158 | bio-research associates | M-SCAN | July 25, 2013 |
| K113677 | medotech | GRINDCARE MEASURE | April 5, 2012 |
| K082927 | bio-research associates | BIOEMG III | February 6, 2009 |
| K043373 | neuromuscular technologies | DOLOTENS DENTAL TM 1 | September 2, 2005 |
| K030869 | s.l.p. | BITESTRIP | May 14, 2004 |
| K003176 | bio-research associates | BIOEMG II AND BIOJVA | January 4, 2001 |
| K003287 | myotronics-noromed | MODEL K7 EVALUATION DEVICE | November 6, 2000 |
| K992694 | myotronics-noromed | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | September 10, 1999 |
| K981563 | bio-research associates | BIOPAK MEASUREMENT SYSTEM | September 15, 1998 |
| K944134 | myo-tronics | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | December 9, 1994 |
| K922456 | myo-tronics | K6-I DIAGNOSTIC SYSTEM | June 9, 1994 |
| K921919 | myo-tronics | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | January 7, 1993 |
| K873947 | bio-research associates | BIO-EMG MODEL 800 | April 27, 1988 |
| K862121 | electronic waveform laboratory | E.W.L. P-TENS/H-WAVE | June 17, 1987 |
| K862092 | m. d. supply | COMFORTRON | October 15, 1986 |
| K850425 | pain prevention | DENTAL ANESTHESIA APPARATUS | October 9, 1986 |
| K830034 | myo-tronics research | MODEL EM-2 BIOELECTRIC PROCESSOR | February 9, 1983 |
| K810528 | myo-tronics research | MODEL EM-IR | March 31, 1981 |