The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Ballancer Gold, 1212.
| Device ID | K190015 |
| 510k Number | K190015 |
| Device Name: | Ballancer Gold, 1212 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Mego Afek AC Ltd. Kibbutz Afek Kibbutz Afek, IL 3004200 |
| Contact | Reuven Yunger |
| Correspondent | Ilan Sharon Mego Afek AC Ltd. P.O. Box 4414 (A109) Caesarea, IL 3088900 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-03 |
| Decision Date | 2019-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290105879165 | K190015 | 000 |