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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K261232
Device Name IERO Mobility Scooter (IERO-01)
Applicant
Jochu Technology Co., Ltd.
# 42, Kuangfu Rd., Hsin Chu Industrial Park,
Hukou Hsin Chu, Taiwan (R.O.C.)
Hsin Chu,  TW
Applicant Contact JIMMY(CHIHMING) WEI
Correspondent
Jochu Technology Co., Ltd.
# 42, Kuangfu Rd., Hsin Chu Industrial Park,
Hukou Hsin Chu, Taiwan (R.O.C.)
Hsin Chu,  TW
Correspondent Contact JIMMY(CHIHMING) WEI
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/15/2026
Decision Date 07/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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