The following data is part of a premarket notification filed by Henley Intl. with the FDA for Curapuls 403 Diathermy Unit.
| Device ID | K900189 |
| 510k Number | K900189 |
| Device Name: | CURAPULS 403 DIATHERMY UNIT |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Henley, Phd |
| Correspondent | Henley, Phd 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 | 1990-01-16 |
| Decision Date | 1990-09-18 |