The following data is part of a premarket notification filed by Dynawave, Corp. with the FDA for Dynasound 801.
| Device ID | K811159 |
| 510k Number | K811159 |
| Device Name: | DYNASOUND 801 |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | DYNAWAVE, CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-28 |
| Decision Date | 1981-05-27 |