The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Ballancer 505 System, Model 1201-ac.
| Device ID | K150269 |
| 510k Number | K150269 |
| Device Name: | Ballancer 505 System, Model 1201-AC |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
| Contact | Aharon Cohen |
| Correspondent | Aharon Cohen 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 | 2015-02-04 |
| Decision Date | 2015-05-26 |