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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 K161458
Device Name Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Applicant
Indiba USA, Inc.
1717 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact Carles Janer
Correspondent
Indiba S.A.
13 - Pol. Ind. Casablancas
Sant Quirze Del Valles,  ES 08192
Correspondent Contact Howard Beaumont
Regulation Number878.4400
Classification Product Code
PBX  
Date Received05/26/2016
Decision Date 10/03/2016
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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