Data / Medical devices / Taiwan / Tung Keng Enterprise Co., Ltd.
Tung Keng Enterprise Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 1 510(k) clearance
Tung Keng Enterprise Co., Ltd. is registered with the FDA (registration 3002667030) in Taichung City, Taiwan. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002667030
- Address
- No.1, Lane 160, Sec. 2, Tanfu Rd., Tantzu, Taichung City, Taiwan, 42748
- Owner or operator
- TUNG KENG ENTERPRISE CO., LTD. (9057632)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 3, 2022
- Registered through
- 2026
- Brand names listed
- Electrically Powered Wheelchair, Joy Rider, Electrically Powered Wheelchair, Zoomer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Powered | ITI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 7, 2022 | K220156 | Electrically Powered Wheelchair, Joy Rider | ITI | Substantially Equivalent | Tung Keng Enterprise Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 1, 2005 | 34405 | Not yet classified | Terminated | The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The pr | The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle. | accessdata.fda.gov |
Compare with other makers
Updated October 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.