Myotronics-Noromed, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Myotronics-Noromed, Inc.” (first 1999, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | 3 | 3 |
| KZM | Device, Muscle Monitoring | 2 | 2 |
| NUW | Stimulator, Muscle, Powered, Dental | 2 | 2 |
Review panels
Most recent Myotronics-Noromed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111687 | EMG SYSTEM | HCC | 2011-09-29 | 105 |
| K040400 | MYO-TRODE SG DISPOSABLE ELECTRODE | NUW | 2004-07-20 | 154 |
| K031998 | MODEL J-5 MVO-MONITOR | NUW | 2003-07-24 | 27 |
| K013399 | MODEL MES-9000/EMG SYSTEM | HCC | 2001-11-13 | 29 |
| K003287 | MODEL K7 EVALUATION DEVICE | KZM | 2000-11-06 | 17 |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | KZM | 1999-09-10 | 29 |
| K992439 | NORODYN 8000 SEMG SYSTEM, ND-8000 | HCC | 1999-08-13 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Myotronics-Noromed, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Myotronics-Noromed, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Myotronics-Noromed, Inc.” (first 1999, latest 2011), 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 Myotronics-Noromed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Myotronics-Noromed, Inc. is 29 days.
Which FDA product codes appear under Myotronics-Noromed, Inc.?
The most frequent FDA product codes under this applicant name are HCC (Device, Biofeedback, 3); KZM (Device, Muscle Monitoring, 2); NUW (Stimulator, Muscle, Powered, Dental, 2).
Next steps
- See all 7 Myotronics-Noromed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCC, Myotronics-Noromed, 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.