Dongguan Prestige Sporting Goods Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Dongguan Prestige Sporting Goods Co., Ltd.” (first 2013, latest 2021), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 306 days. Since 2017 the median was 336 days, against 168 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 |
|---|---|---|
| 2013 | 1 | 203 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 336 |
| 2019 | 1 | 244 |
| 2020 | 2 | 424 |
| 2021 | 7 | 368 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dongguan Prestige Sporting Goods Co., Ltd. took a median 336 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 168 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 6 | 6 |
| ITI | Wheelchair, Powered | 5 | 5 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
Review panels
- Physical Medicine (11)
- General Hospital (1)
Most recent Dongguan Prestige Sporting Goods Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143) | INI | 2021-05-10 | 780 |
| K192190 | Solax Electric Scooter | INI | 2021-04-23 | 619 |
| K200978 | Electric Wheelchair (Model: S7110) | ITI | 2021-04-16 | 368 |
| K202632 | Electric wheelchair (S7204/S7205) | ITI | 2021-04-08 | 209 |
| K201508 | Infrared Thermometer | FLL | 2021-03-09 | 277 |
| K202549 | Solax Electric Scooter (Model: S202261B) | INI | 2021-02-26 | 176 |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) | INI | 2021-02-10 | 575 |
| K200857 | Electric wheelchair (Model: S7012) | ITI | 2020-12-17 | 260 |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103) | ITI | 2020-04-14 | 588 |
| K182576 | Solax Powered Wheelchair | ITI | 2019-05-21 | 244 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dongguan Prestige Sporting Goods Co., Ltd..
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.
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.
- Dongguan TT Medical, Inc. (6 510(k)s)
- Dongguan E-Test Technology Co., Ltd. (5 510(k)s)
- Dongguan Boyuan Intelligent Technology Co.,Ltd (4 510(k)s)
- Dongguan Simzo Electronic Technology Co., Ltd. (3 510(k)s)
- Dongguan Ageless Health Industrial Co., Ltd. (2 510(k)s)
- Dongguan Hunter Electronic Technology Co., Ltd. (2 510(k)s)
- Dongguan Kangweile Electronic Technology Co., Ltd. (2 510(k)s)
- Dongguan Lide Electric Appliance Co., Ltd. (2 510(k)s)
- Dongguan Shin YI Healthcare Products Factory (2 510(k)s)
- Dongguan Smarfody Mobility Technology Co., Ltd. (2 510(k)s)
- Dongguan Tutamen Metalwork Co., Ltd. (2 510(k)s)
- Dongguan Xiangtong Co., Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dongguan Prestige Sporting Goods Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Dongguan Prestige Sporting Goods Co., Ltd.” (first 2013, latest 2021), 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 Dongguan Prestige Sporting Goods Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dongguan Prestige Sporting Goods Co., Ltd. is 306 days. Since 2017: 336 days, versus 168 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dongguan Prestige Sporting Goods Co., Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 6); ITI (Wheelchair, Powered, 5); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 12 Dongguan Prestige Sporting Goods Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Dongguan Prestige Sporting Goods Co., Ltd.'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.