K230385 is an FDA 510(k) clearance for the Ballancer Platinum (1222). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Mego Afek (Kibbuts Afek, IL). The FDA issued a Cleared decision on April 4, 2023, 49 days after receiving the submission on February 14, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K230385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2023 |
| Decision Date | April 04, 2023 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |