Kwang Yang Motor Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Kwang Yang Motor Co., Ltd.” (first 2007, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 | 1 | 186 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 121 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Kwang Yang Motor Co., Ltd. took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 6 | 6 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Kwang Yang Motor Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163201 | KYMCO EQ10D Scooter | INI | 2017-03-16 | 121 |
| K130940 | KYMCO EQ20C SCOOTER | INI | 2013-10-07 | 186 |
| K082901 | KYMCO FORU, MODEL EQ20 | INI | 2008-10-28 | 28 |
| K082900 | KYMCO FORU, MODEL EQ10 | INI | 2008-10-28 | 28 |
| K081133 | KYMCO FORU, MODEL EQ40 | INI | 2008-06-10 | 50 |
| K072630 | FORU, MODEL EQ30 | INI | 2007-10-03 | 15 |
| K072027 | FORU KV10HB | ITI | 2007-08-20 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Kwang Yang Motor 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.
- Kwang Myung Daicom, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kwang Yang Motor Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Kwang Yang Motor Co., Ltd.” (first 2007, latest 2017), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Kwang Yang Motor Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kwang Yang Motor Co., Ltd. is 28 days.
Which FDA product codes appear under Kwang Yang Motor Co., Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 6); ITI (Wheelchair, Powered, 1).
Next steps
- See all 7 Kwang Yang Motor Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Kwang Yang Motor 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 (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.