Tung Keng Enterprise Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Tung Keng Enterprise Co., Ltd.” (first 2003, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 261 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tung Keng Enterprise Co., Ltd. took a median 261 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 | 5 | 5 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
Most recent Tung Keng Enterprise Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220156 | Electrically Powered Wheelchair, Joy Rider | ITI | 2022-10-07 | 261 |
| K033240 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 | INI | 2003-12-18 | 73 |
| K033220 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 | INI | 2003-12-18 | 76 |
| K033239 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 | INI | 2003-11-12 | 37 |
| K033219 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 | INI | 2003-11-12 | 40 |
| K033241 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 | INI | 2003-11-10 | 35 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2005-11-01.
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.
- Tung FU Electric Co., Ltd. (2 510(k)s)
- Tung Fang Mei Shieh Co., Ltd. (1 510(k)s)
- Tung Kuang Rubber Factory Co. , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tung Keng Enterprise Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Tung Keng Enterprise Co., Ltd.” (first 2003, latest 2022), 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 Tung Keng Enterprise Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tung Keng Enterprise Co., Ltd. is 56 days.
Which FDA product codes appear under Tung Keng Enterprise Co., Ltd.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 5); ITI (Wheelchair, Powered, 1).
Next steps
- See all 6 Tung Keng Enterprise Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code INI, Tung Keng Enterprise 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.