K211207 is an FDA 510(k) clearance for the Diacare 7000. This device is classified as a Massager, Vacuum, Radio Frequency Induced Heat (Class II - Special Controls, product code PBX).
Submitted by Globus Sport and Health Technologies, LLC (Miami, US). The FDA issued a Cleared decision on June 6, 2022, 410 days after receiving the submission on April 22, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite..
| 510(k) Number | K211207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2021 |
| Decision Date | June 06, 2022 |
| Days to Decision | 410 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PBX - Massager, Vacuum, Radio Frequency Induced Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite. |