K190015 is an FDA 510(k) clearance for the Ballancer Gold, 1212. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Mego Afek AC , Ltd. (Kibbutz Afek, IL). The FDA issued a Cleared decision on March 25, 2019, 81 days after receiving the submission on January 3, 2019.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K190015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2019 |
| Decision Date | March 25, 2019 |
| Days to Decision | 81 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 |