The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Therapeutic Stimulator 2100 (ts-2100).
| Device ID | K914904 |
| 510k Number | K914904 |
| Device Name: | THERAPEUTIC STIMULATOR 2100 (TS-2100) |
| Classification | Stimulator, Muscle, Powered |
| Applicant | MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
| Contact | Hassan Hamedi |
| Correspondent | Hassan Hamedi MYO/KINETIC SYSTEMS, INC. N84 W13562 LEON RD. Menomonee Falls, WI 53051 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-01 |
| Decision Date | 1992-04-28 |