Dynatronics Corp.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under 2 spellings of the applicant name “Dynatronics Corp.” (first 1987, latest 2014), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 146 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 | 2 | 126 |
| 2013 | 0 | — |
| 2014 | 1 | 205 |
| 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 |
|---|---|---|---|
| LIH | Interferential Current Therapy | 7 | 7 |
| ILY | Lamp, Infrared, Therapeutic Heating | 4 | 4 |
| EGJ | Device, Iontophoresis, Other Uses | 2 | 2 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IKE | Transducer, Miniature Pressure | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
- Physical Medicine (14)
- Neurology (11)
Most recent Dynatronics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132057 | DYNATRON PELTIER THERMOSTIM PROBE | GXY | 2014-01-24 | 205 |
| K120835 | DYNATRON THERMOSTIM PROBE-DONE | GXY | 2012-08-20 | 153 |
| K113250 | DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE | ILY | 2012-02-09 | 98 |
| K060814 | DYNATRON ION IONTOPHORESIS ELECTRODE | EGJ | 2006-06-14 | 79 |
| K051680 | DYNATRON DX2 TRACTION UNIT | ILY | 2005-10-11 | 110 |
| K051261 | DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE | ILY | 2005-07-25 | 70 |
| K043047 | DYNATRON IBOX IONTOPHORESIS DEVICE | EGJ | 2005-01-07 | 64 |
| K040729 | SOLARIS D890 THERAPY PROBE | ILY | 2004-06-02 | 72 |
| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | IMI | 2003-10-22 | 177 |
| K010948 | DYNATRON STS RX | LIH | 2001-05-15 | 47 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dynatronics Corp..
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Dynatronics Corp. (24)
- Dynatronics Corporation (1)
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.
- Dynatronics Laser Corp. (5 510(k)s)
- Dynatronics Research Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dynatronics Corp.?
FDA lists 25 510(k) clearances under 2 spellings of the applicant name “Dynatronics Corp.” (first 1987, latest 2014), across 11 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 Dynatronics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dynatronics Corp. is 146 days.
Which FDA product codes appear under Dynatronics Corp.?
The most frequent FDA product codes under this applicant name are LIH (Interferential Current Therapy, 7); ILY (Lamp, Infrared, Therapeutic Heating, 4); EGJ (Device, Iontophoresis, Other Uses, 2).
Next steps
- See all 25 Dynatronics Corp. clearances with predicates and recalls
- Run predicate analysis for product code LIH, Dynatronics Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.