FDA 510(k) Application Details - K240339

Device Classification Name Wheelchair, Powered

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510(K) Number K240339
Device Name Wheelchair, Powered
Applicant Shanghai Bangbang Robotics Co., Ltd
Room 501, Building 3, No.188 Zhongchen Road
Songjiang District
Shanghai CN
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Contact Canfeng Liu
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 02/05/2024
Decision Date 07/22/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240339


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