The following data is part of a premarket notification filed by Dynawave, Corp. with the FDA for Dynasound Model 401 Therapeutic Ultrasound Stimulator.
| Device ID | K934287 |
| 510k Number | K934287 |
| Device Name: | DYNASOUND MODEL 401 THERAPEUTIC ULTRASOUND STIMULATOR |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | DYNAWAVE, CORP. 2520 KANEVILLE COURT Geneva, IL 60134 |
| Contact | C.r. Kesner |
| Correspondent | C.r. Kesner DYNAWAVE, CORP. 2520 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-02 |
| Decision Date | 1994-04-04 |