The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Recovery Pump, 737r (rpx).
| Device ID | K190493 |
| 510k Number | K190493 |
| Device Name: | Recovery Pump, 737R (RPX) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
| Contact | Reuven Yunger |
| Correspondent | Reuven Yunger Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00074676006895 | K190493 | 000 |
| 00074676006864 | K190493 | 000 |
| 00074676006833 | K190493 | 000 |
| 07290116950044 | K190493 | 000 |
| 07290105879325 | K190493 | 000 |