Submission Details
| 510(k) Number | K924970 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | September 30, 1992 |
| Decision Date | October 03, 1994 |
| Days to Decision | 733 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K924970 is an FDA 510(k) clearance for the FEMININE HEAT WRAP, 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 3, 1994, 733 days after receiving the submission on September 30, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.
| 510(k) Number | K924970 FDA.gov |
| FDA Decision | Cleared SN |
| Date Received | September 30, 1992 |
| Decision Date | October 03, 1994 |
| Days to Decision | 733 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IRT — Pad, Heating, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.5740 |