The following data is part of a premarket notification filed by Dr. Oliver Wenker, M.d., M.b.a. with the FDA for Futura.
| Device ID | K102524 |
| 510k Number | K102524 |
| Device Name: | FUTURA |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | DR. OLIVER WENKER, M.D., M.B.A. 2300 VALLEY VIEW LANE, SUITE 230 Farmers Branch, TX 75234 |
| Contact | Courtland Imel |
| Correspondent | Courtland Imel DR. OLIVER WENKER, M.D., M.B.A. 2300 VALLEY VIEW LANE, SUITE 230 Farmers Branch, TX 75234 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2011-11-03 |
| Summary: | summary |