The following data is part of a premarket notification filed by Indiba Usa Inc. with the FDA for Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care.
| Device ID | K161458 |
| 510k Number | K161458 |
| Device Name: | Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Indiba USA Inc. 1717 Embarcadero Road Palo Alto, CA 94303 |
| Contact | Carles Janer |
| Correspondent | Howard Beaumont Indiba S.A. 13 - Pol. Ind. Casablancas Sant Quirze Del Valles, ES 08192 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-26 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08434251000915 | K161458 | 000 |
| 08434251000229 | K161458 | 000 |