The following data is part of a premarket notification filed by Mego Afek Ac Ltd with the FDA for Dsj Massager.
| Device ID | K112479 |
| 510k Number | K112479 |
| Device Name: | DSJ MASSAGER |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | MEGO AFEK AC LTD 1050 CONNECTICUT AVENUE, NW. Washington, DC 20036 |
| Contact | James R Ravitz, Esq. |
| Correspondent | James R Ravitz, Esq. MEGO AFEK AC LTD 1050 CONNECTICUT AVENUE, NW. Washington, DC 20036 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2011-12-07 |