The following data is part of a premarket notification filed by Henley Intl. with the FDA for Curapuls 419 Diathermy Unit.
| Device ID | K861248 |
| 510k Number | K861248 |
| Device Name: | CURAPULS 419 DIATHERMY UNIT |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Davis C Henley |
| Correspondent | Davis C Henley HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-05-30 |