The following data is part of a premarket notification filed by Henley Intl. with the FDA for Sonopuls 591.
| Device ID | K922036 |
| 510k Number | K922036 |
| Device Name: | SONOPULS 591 |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley |
| Correspondent | Ernest J Henley HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-01 |
| Decision Date | 1993-06-29 |