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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K253542
Device Name Apollo Quattro (APQ-10M)
Applicant
Weero Co., Ltd.
A-205, Venture Valley Ii, 142-10, Saneop-Ro 156 Beon-Gil
Gwonseon-Gu Suwon-Si,Gyeonggi-Do
Suwon,  KR 16648
Applicant Contact Han Moon young
Correspondent
Weero Co., Ltd.
A-205, Venture Valley Ii, 142-10, Saneop-Ro 156 Beon-Gil
Gwonseon-Gu Suwon-Si,Gyeonggi-Do
Suwon,  KR 16648
Correspondent Contact Han Moon young
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   IRT  
Date Received11/14/2025
Decision Date 06/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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