K803177 is an FDA 510(k) clearance for the MOIST HEAT PACK. This device is classified as a Pack, Heat, Moist (Class I - General Controls, product code IMA).
Submitted by Duro-Med Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980, 15 days after receiving the submission on December 16, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5730.
| 510(k) Number | K803177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1980 |
| Decision Date | December 31, 1980 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMA — Pack, Heat, Moist |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5730 |