K163280 is an FDA 510(k) clearance for the RP Lite 760R. 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 January 27, 2017, 67 days after receiving the submission on November 21, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K163280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2016 |
| Decision Date | January 27, 2017 |
| Days to Decision | 67 days |
| Submission Type | Special |
| 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 |