Staodynamics, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Staodynamics, Inc.” (first 1979, latest 1985), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| GXY | Electrode, Cutaneous | 3 | 3 |
| IPF | Stimulator, Muscle, Powered | 3 | 3 |
| BWJ | Locator, Acupuncture Point | 2 | 2 |
| IMA | Pack, Heat, Moist | 1 | 1 |
Plus 1 more product codes.
Review panels
- Neurology (7)
- Physical Medicine (4)
- General Hospital (2)
Most recent Staodynamics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852298 | TENS-AID STERILE ELECTRODES FOR POST-OP TENS | GXY | 1985-06-24 | 26 |
| K843964 | TENS-AID PREMIUM ELECTRODES | GXY | 1985-02-25 | 137 |
| K832988 | STAODYN EMS/PLUS | IPF | 1983-11-22 | 82 |
| K813283 | 10D (TENS DEVICE) | GZJ | 1982-02-10 | 79 |
| K813098 | TENS DEVICE | — | 1981-11-20 | 17 |
| K811345 | INSIGHT | GZJ | 1981-07-10 | 59 |
| K792529 | POINT LOCATOR STIMULATOR | BWJ | 1980-02-26 | 81 |
| K792501 | PLS MINI | BWJ | 1980-02-26 | 84 |
| K800068 | ELECTRICAL MUSCLE STIMULATOR (EMS) | IPF | 1980-02-05 | 25 |
| K792502 | TENS 4100 | GZJ | 1979-12-18 | 14 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Staodynamics, 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 Staodynamics, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Staodynamics, Inc.” (first 1979, latest 1985), across 6 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 Staodynamics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Staodynamics, Inc. is 60 days.
Which FDA product codes appear under Staodynamics, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); GXY (Electrode, Cutaneous, 3); IPF (Stimulator, Muscle, Powered, 3).
Next steps
- See all 14 Staodynamics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Staodynamics, 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.