The following data is part of a premarket notification filed by Health@fitness Technologies, Inc. with the FDA for Muscle Stimulator Sa-100.
| Device ID | K010807 |
| 510k Number | K010807 |
| Device Name: | MUSCLE STIMULATOR SA-100 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | HEALTH@FITNESS TECHNOLOGIES, INC. KARAMANOVA 11 21000 Split, HR 21000 |
| Contact | Ivan Vrdoljak |
| Correspondent | Ivan Vrdoljak HEALTH@FITNESS TECHNOLOGIES, INC. KARAMANOVA 11 21000 Split, HR 21000 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-16 |
| Decision Date | 2001-08-09 |