Data / Medical devices / United States / Myotronics-Noromed, Inc.
Myotronics-Noromed, Inc.: FDA-registered device maker in Kent, WA, United States, 5 510(k) clearances
Myotronics-Noromed, Inc. is registered with the FDA (registration 3014732) in Kent, WA, United States. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 20, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014732
- Address
- 5870 S. 194TH ST., Kent, WA, United States, 98032
- Owner or operator
- MYOTRONICS-NOROMED, INC. (3014732)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 31, 1992
- Registered through
- 2026
- Brand names listed
- ESG-1 ELECTROSONOGRAM, MES-9000 EMG SYSTEM, MODEL J-5 MYOMONITOR, MODEL K7 EVALUATION SYSTEM, MYOTRODE SG DISPOSABLE ELECTRODES, TERMINUS ARTICULATOR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Articulators | EJP | 1 | Manufacturer | accessdata.fda.gov |
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Device, Dental Sonography, For Monitoring Jaw Sounds | NFQ | 1 | Manufacturer | accessdata.fda.gov |
| Device, Jaw Tracking, For Monitoring Jaw Positions | NFS | 1 | Manufacturer | accessdata.fda.gov |
| Device, Muscle Monitoring | KZM | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, Dental | NUW | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 20, 2004 | K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | NUW | Substantially Equivalent | Myotronics-Noromed, Inc. | accessdata.fda.gov |
| July 24, 2003 | K031998 | MODEL J-5 MVO-MONITOR | NUW | Substantially Equivalent | Myotronics-Noromed, Inc. | accessdata.fda.gov |
| November 13, 2001 | K013399 | MODEL MES-9000/EMG SYSTEM | HCC | Substantially Equivalent | Myotronics-Noromed, Inc. | accessdata.fda.gov |
| November 6, 2000 | K003287 | MODEL K7 EVALUATION DEVICE | KZM | Substantially Equivalent | Myotronics-Noromed, Inc. | accessdata.fda.gov |
| April 2, 1997 | K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | NFQ | Substantially Equivalent | Myo-Tronics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Muscle Monitoring
- All makers of Articulators
- All makers of Stimulator, Muscle, Powered, Dental
- All makers of Device, Jaw Tracking, For Monitoring Jaw Positions
- All makers of Device, Dental Sonography, For Monitoring Jaw Sounds
- All makers of Device, Biofeedback
Updated July 20, 2004. 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.