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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K241107
Device Name Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
Applicant
Indiba S. A. U.
C/ Moianès, 13 - P.I. Can Casablanques
Sant Quirze Del Vallès (Barcelona),  ES 08192
Applicant Contact Amit Goren
Correspondent
A. Stein Regulatory Affairs Consulting Company , Ltd.
18 Hata'As St.
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number878.4400
Classification Product Code
PBX  
Date Received04/22/2024
Decision Date 01/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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