FDA 510(k)

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01

Numéro K : K231868 · 2023-10-31

DemandeurShanghai Bangbang Robotics Co., Ltd.

Date de décision2023-10-31

Code produitITI

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231868. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Shanghai Bangbang Robotics Co., Ltd.. The 510(k) number is K231868.

When did Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 receive FDA 510(k) clearance?

Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231868.

Who is the listed applicant for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

The FDA 510(k) record lists Shanghai Bangbang Robotics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01?

The FDA product code for Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 is ITI.

Essais cliniques associés

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Autres dossiers indiquant Shanghai Bangbang Robotics Co., Ltd. en tant que demandeur

Dispositifs connexes (Code : ITI)

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.

Source officielle

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