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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K202395
Device Name SP-1000, SP-2000
Applicant
Daesung Maref Co., Ltd.
298-24, Gongdan-Ro
Gunpo-Si,  KR 15809
Applicant Contact Hyoung Ju Cho
Correspondent
Global Medical Standard Consulting Co., Ltd.
34, Sangamsan-Ro, Mapo-Gu
Seoul,  KR 03909
Correspondent Contact Do Gyun Lim
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/21/2020
Decision Date 09/01/2021
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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