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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 K232786
Device Name Stimulation System (PA series, PR series, S series and Q series)
Applicant
Edan Instruments, Inc.
#15 Jinhui Road, Pingshan District
Shenzhen,  CN 518122
Applicant Contact Tracy Yue
Correspondent
Edan Instruments, Inc.
#15 Jinhui Road, Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Tracy Yue
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received09/11/2023
Decision Date 05/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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