Hong Qiangxing (Shenzhen) Electronics Limited: FDA clearances and approvals
Hong Qiangxing (Shenzhen) Electronics Limited has 9 FDA 510(k) clearances (first 2013, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time: 132 days. Since 2017 its median was 90 days, against 138 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 333 |
| 2014 | 1 | 309 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 232 |
| 2020 | 1 | 204 |
| 2021 | 0 | — |
| 2022 | 3 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 29 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Hong Qiangxing (Shenzhen) Electronics Limited's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 5 | 5 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
Review panels
- Neurology (6)
- Physical Medicine (3)
Most recent Hong Qiangxing (Shenzhen) Electronics Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253740 | TENS&EMS (HZ9151B, HZ9151C, HZ9151D) | NUH | 2025-12-23 | 29 |
| K220283 | TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) | NUH | 2022-05-02 | 90 |
| K220152 | TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) | NUH | 2022-04-19 | 90 |
| K220150 | TENS & PMS (Model: SM9126) | NUH | 2022-02-17 | 29 |
| K201354 | TENS & PMS | NGX | 2020-12-11 | 204 |
| K190009 | Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) | NUH | 2019-12-02 | 333 |
| K183154 | SM Electrodes | GXY | 2019-03-26 | 132 |
| K133108 | FIT BELT | NGX | 2014-08-05 | 309 |
| K121719 | SM TENS & PMS | NGX | 2013-05-10 | 333 |
Recalls
openFDA lists no recalls under a recalling firm named Hong Qiangxing (Shenzhen) Electronics Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hong Qiangxing (Shenzhen) Electronics Limited have?
Hong Qiangxing (Shenzhen) Electronics Limited has 9 FDA 510(k) clearances (first 2013, latest 2025), across 3 product codes in 2 review panels.
How long does FDA take to clear Hong Qiangxing (Shenzhen) Electronics Limited's 510(k)s?
The median time from FDA receipt to decision across Hong Qiangxing (Shenzhen) Electronics Limited's cleared 510(k)s is 132 days. Since 2017: 90 days, versus 138 days for all cleared 510(k)s in the same product codes.
What devices does Hong Qiangxing (Shenzhen) Electronics Limited make?
Its most frequent FDA product codes are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 5); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 3); GXY (Electrode, Cutaneous, 1).
Has Hong Qiangxing (Shenzhen) Electronics Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Hong Qiangxing (Shenzhen) Electronics Limited. Related entities may recall under other names.
Next steps
- See all 9 Hong Qiangxing (Shenzhen) Electronics Limited clearances with predicates and recalls
- Run predicate analysis for product code NUH, Hong Qiangxing (Shenzhen) Electronics Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.