Hi-Dow International, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hi-Dow International, Inc.” (first 2011, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 182 days. Since 2017 the median was 120 days, against 137 days for all cleared 510(k)s in the same product codes. 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 | 1 | 245 |
| 2018 | 0 | — |
| 2019 | 1 | 113 |
| 2020 | 1 | 120 |
| 2021 | 1 | 276 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 88 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hi-Dow International, Inc. took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 137 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 3 | 3 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| ILX | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (1)
Most recent Hi-Dow International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233461 | Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) | NUH | 2024-01-19 | 88 |
| K210383 | Wrap Accessory Electrodes | GXY | 2021-11-12 | 276 |
| K202337 | Pulsed electromagnetic field wrap | ILX | 2020-12-15 | 120 |
| K190617 | Wrap accessory electrodes | GXY | 2019-07-02 | 113 |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | NUH | 2017-08-04 | 245 |
| K102598 | HI-DOW-XP | NUH | 2011-05-13 | 245 |
Recalls
openFDA lists no recalls under a recalling firm named Hi-Dow International, 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 Hi-Dow International, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Hi-Dow International, Inc.” (first 2011, latest 2024), 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 Hi-Dow International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hi-Dow International, Inc. is 182 days. Since 2017: 120 days, versus 137 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hi-Dow International, Inc.?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 3); GXY (Electrode, Cutaneous, 2); ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat, 1).
Next steps
- See all 6 Hi-Dow International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NUH, Hi-Dow International, 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.