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FDA 510(k), K161458, Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
FDA 510(k), K161458, Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
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510(K) Number: K161458
Device Name: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Manufacturer: Indiba USA Inc.
Device Classification Name: massager, vacuum, radio frequency induced heat
Regulation Number: 878.4400
Classification Product Code: PBX
Date Received: 05/26/2016
Decision Date: 10/03/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Manufacturer: Indiba USA Inc.
Device Classification Name: massager, vacuum, radio frequency induced heat
Regulation Number: 878.4400
Classification Product Code: PBX
Date Received: 05/26/2016
Decision Date: 10/03/2016
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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