Submission Details
| 510(k) Number | K924885 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 1992 |
| Decision Date | October 12, 1993 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
K924885 is an FDA 510(k) clearance for the KING SIZE HEAT PAD, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993, 379 days after receiving the submission on September 28, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.
| 510(k) Number | K924885 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 28, 1992 |
| Decision Date | October 12, 1993 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRT — Pad, Heating, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5740 |