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FDA 510(k)

BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500

K-Number: K033239 · 2003-11-12

ApplicantTung Keng Enterprise Co., Ltd.
Decision Date2003-11-12
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 is the device name listed in this FDA 510(k) record. The listed applicant is Tung Keng Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K033239. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500?

BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Tung Keng Enterprise Co., Ltd.. The 510(k) number is K033239.

When did BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 receive FDA 510(k) clearance?

BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 received FDA 510(k) clearance on 2003-11-12, under 510(k) number K033239.

Who is the listed applicant for BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500?

The FDA 510(k) record lists Tung Keng Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500?

The FDA product code for BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 is INI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Tung Keng Enterprise Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220156Electrically Powered Wheelchair, Joy RiderK033240BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200K033220BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280K033219BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600K033241BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320

Related Devices (Code: INI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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