The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Rp Lite 760r.
| Device ID | K163280 |
| 510k Number | K163280 |
| Device Name: | RP Lite 760R |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon Ilan Sharon Consultant Neot Golf A109 Caesarea, IL 3088900 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00074676007229 | K163280 | 000 |
| 00074676006956 | K163280 | 000 |
| 00074676006987 | K163280 | 000 |
| 00074676007014 | K163280 | 000 |
| 80074676007041 | K163280 | 000 |
| 80074676007072 | K163280 | 000 |
| 80074676007102 | K163280 | 000 |
| 80074676007133 | K163280 | 000 |
| 00074676007168 | K163280 | 000 |
| 00074676007199 | K163280 | 000 |
| 07290116950013 | K163280 | 000 |