Myo-Tronics Research, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Myo-Tronics Research, Inc.” (first 1977, latest 1984), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| NUW | Stimulator, Muscle, Powered, Dental | 3 | 3 |
| KZM | Device, Muscle Monitoring | 2 | 2 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| EFH | Paper, Articulation | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Dental (6)
- Immunology (1)
- Physical Medicine (1)
Most recent Myo-Tronics Research, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K842224 | BNS 40 | NUW | 1984-11-19 | 167 |
| K842223 | J4 MYO-MONITOR | NUW | 1984-11-19 | 167 |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | EFH | 1984-02-10 | 150 |
| K831364 | TESTCORP RA | DCN | 1983-05-27 | 31 |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | KZM | 1983-02-09 | 33 |
| K813533 | ELECTRIC MUSCLE STIMULATOR | IPF | 1982-03-05 | 78 |
| K810528 | MODEL EM-IR | KZM | 1981-03-31 | 33 |
| K770252 | MONITOR, MYO, MODEL J3 | NUW | 1977-02-18 | 9 |
Recalls
openFDA lists no recalls under a recalling firm named Myo-Tronics Research, 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, Inc. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Myo-Tronics Research, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Myo-Tronics Research, Inc.” (first 1977, latest 1984), across 5 product codes in 3 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 Research, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myo-Tronics Research, Inc. is 56 days.
Which FDA product codes appear under Myo-Tronics Research, Inc.?
The most frequent FDA product codes under this applicant name are NUW (Stimulator, Muscle, Powered, Dental, 3); KZM (Device, Muscle Monitoring, 2); DCN (System, Test, C-Reactive Protein, 1).
Next steps
- See all 8 Myo-Tronics Research, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUW, Myo-Tronics Research, 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.