K140519 is an FDA 510(k) clearance for the RECOVERY PUMP 737R. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Mego Afek AC , Ltd. (Afek, IL). The FDA issued a Cleared decision on June 16, 2014, 108 days after receiving the submission on February 28, 2014.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K140519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2014 |
| Decision Date | June 16, 2014 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |