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Tung Keng Enterprise Co., Ltd.

FDA Regulatory Profile

Tung Keng Enterprise Co., Ltd. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 9, 2025 · NAI
Latest 510(k)
Oct 7, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 9, 2025Tai-Tzu Hsiang, Taichung County, TaiwanDevicesNo Action Indicated (NAI)3002667030

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K220156Electrically Powered Wheelchair, Joy RiderOct 7, 2022
K033240BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200Dec 18, 2003
K033220BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280Dec 18, 2003
K033239BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500Nov 12, 2003
K033219BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600Nov 12, 2003
K033241BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320Nov 10, 2003

FDA data resources