Myo-Tronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Myo-Tronics, Inc. makes
Myo-Tronics, Inc. manufactures diagnostic devices for electromyography (EMG) and muscle function assessment, including handheld scanners like the MS-100 MYO-SCANNER and the ESG-1 ELECTROSONOGRAM for nerve and muscle signal analysis. Their portfolio also includes systems like the PHYSIOTECH 4000/NORODYN 8000 for muscle stimulation and diagnostic evaluation, as well as the K6-I diagnostic system for EMG testing. These devices are designed for clinical and research use in assessing neuromuscular conditions.
The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. They are listed in the FDA’s 510(k) clearance registry, reflecting their compliance with U.S. medical device regulations. Myo-Tronics, Inc. is headquartered in the United States.
Catalogue
Ms-100 Myo-Scanner Or Ms-100 Emg Scanner Ref K921919
Regimes: 510(k) Registry: 510(k)Electrosonogram Esg-1 Ref K905449
Regimes: 510(k) Registry: 510(k)Esg-1 Electrosonogram (Esg-1) Ref K970116
Regimes: 510(k) Registry: 510(k)Physiotech 4000 Or Norodyn 8000 Ref K922270
Regimes: 510(k) Registry: 510(k)K6-I Diagnostic System Ref K922456
Regimes: 510(k) Registry: 510(k)K6-1 Diagnostic System Version 3.1 Ref K944134
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Myo-Tronics, Inc. have in the registry?
The registry currently lists 6 devices for Myo-Tronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Myo-Tronics, Inc.'s devices?
Among its 6 most recently registered devices, Myo-Tronics, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Myo-Tronics, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Myo-Tronics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Myo-Tronics, Inc. in the registry?
The most recently registered devices listed for Myo-Tronics, Inc. include MS-100 MYO-SCANNER OR MS-100 EMG SCANNER, ELECTROSONOGRAM ESG-1, ESG-1 ELECTROSONOGRAM (ESG-1) and PHYSIOTECH 4000 OR NORODYN 8000.