FDA 510(k) Application Details - K241641

Device Classification Name Wheelchair, Powered

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510(K) Number K241641
Device Name Wheelchair, Powered
Applicant Shenzhen Yattll Industry Co., Ltd
Room 907, A&I International Center, No. 8 Gaoerfu blvd,
Longhua Dist
Shenzhen 518100 CN
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Contact Kevin Shih
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 06/07/2024
Decision Date 01/11/2025
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 K241641


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