Tung Keng Enterprise Co., Ltd.
Taichung City, TW
TUNG KENG ENTERPRISE CO., LTD. appears in FDA device records in Taichung City, TW. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Tung Keng Enterprise Co., Ltd. between 2003 and 2022. The busiest year on record is 2003, with 5. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 5 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220156 | Electrically Powered Wheelchair, Joy Rider | ITI | Substantially Equivalent | |
| K033240 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 | INI | Substantially Equivalent | |
| K033220 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 | INI | Substantially Equivalent | |
| K033239 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 | INI | Substantially Equivalent | |
| K033219 | BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 | INI | Substantially Equivalent | |
| K033241 | BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 | INI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002667030 | 3002667030 | TUNG KENG ENTERPRISE CO., LTD. | No.1, Lane 160, Sec. 2, Tanfu Rd., Tantzu, Taichung City 42748 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0522-06 | The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation. | The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle. | Terminated | ||
| Z-0521-06 | 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 product is distributed by the Invacare Corporation. | The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain