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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K240168
Device Name N7-S
Applicant
Nuga Medical Co., Ltd.
185, Jiraeul-Ro, Jijeong-Myeon
Wonju-Si,  KR 26355
Applicant Contact Jun Woo Lee
Correspondent
Nuga Medical Co., Ltd.
185, Jiraeul-Ro, Jijeong-Myeon
Wonju-Si,  KR 26355
Correspondent Contact Jun Woo Lee
Regulation Number890.5880
Classification Product Code
JFB  
Subsequent Product Code
IRP  
Date Received01/22/2024
Decision Date 09/12/2024
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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