Data / Medical devices / Device, Muscle Monitoring
Device, Muscle Monitoring (KZM): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Device, Muscle Monitoring (product code KZM, Class 2, 21 CFR 890.1375). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on December 21, 2016, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KZM
- Device class
- 2
- Regulation
- 890.1375
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Italy | 1 |
| Estonia | 1 |
| China | 1 |
| Iceland | 1 |
Makers of Device, Muscle Monitoring
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bio-Research Associates, Inc. | Mequon, WI, United States | Complaint file establishment, Manufacturer | 3 | July 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| BTS SPA | VIGONZA Padova, Italy | Manufacturer | 1 | December 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Electronic Waveform Lab, Inc. | Huntingtn Bch, CA, United States | Specification developer | 1 | June 17, 1987 | 0 | 0 | 0 | api.fda.gov |
| Myotronics-Noromed, Inc. | Kent, WA, United States | Manufacturer | 1 | November 6, 2000 | 0 | 0 | 0 | api.fda.gov |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nox Medical | Reykjavik, Iceland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 21, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.