Myo-Tronics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Myo-Tronics, Inc.” (first 1991, latest 1997), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 200 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | 3 | 3 |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 2 | 2 |
| HCC | Device, Biofeedback | 1 | 1 |
Review panels
Most recent Myo-Tronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | NFQ | 1997-04-02 | 79 |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | KZM | 1994-12-09 | 107 |
| K922270 | PHYSIOTECH 4000 OR NORODYN 8000 | HCC | 1994-09-02 | 841 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | KZM | 1994-06-09 | 744 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | KZM | 1993-01-07 | 259 |
| K905449 | ELECTROSONOGRAM ESG-1 | NFQ | 1991-04-26 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Myo-Tronics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Myo-Tronics Research, Inc. (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Myo-Tronics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Myo-Tronics, Inc.” (first 1991, latest 1997), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Myo-Tronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myo-Tronics, Inc. is 200 days.
Which FDA product codes appear under Myo-Tronics, Inc.?
The most frequent FDA product codes under this applicant name are KZM (Device, Muscle Monitoring, 3); NFQ (Device, Dental Sonography, For Monitoring Jaw Sounds, 2); HCC (Device, Biofeedback, 1).
Next steps
- See all 6 Myo-Tronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KZM, Myo-Tronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.