The following data is part of a premarket notification filed by Alfa Tech Medical Systems, Ltd. with the FDA for Tnn-du810 Non-invasive Subdermal Therapy System.
| Device ID | K063728 |
| 510k Number | K063728 |
| Device Name: | TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | ALFA TECH MEDICAL SYSTEMS, LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk ALFA TECH MEDICAL SYSTEMS, LTD. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | IMG |
| Subsequent Product Code | IMI |
| Subsequent Product Code | IPF |
| Subsequent Product Code | ISA |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-15 |
| Decision Date | 2007-04-04 |
| Summary: | summary |