The following data is part of a premarket notification filed by Ferno with the FDA for Ferno Ille Inferno Moist Heat Therapy Ut, 916/917.
| Device ID | K924023 |
| 510k Number | K924023 |
| Device Name: | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 |
| Classification | Unit, Heating, Powered |
| Applicant | FERNO 70 WEIL WAY Wilmington, OH 45177 |
| Contact | Eric N Besanko |
| Correspondent | Eric N Besanko FERNO 70 WEIL WAY Wilmington, OH 45177 |
| Product Code | IRQ |
| CFR Regulation Number | 890.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-11 |
| Decision Date | 1993-04-14 |