K941245 is an FDA 510(k) clearance for the POLY-MEDICS HEAT PACK. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 2, 1994, 48 days after receiving the submission on March 15, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K941245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1994 |
| Decision Date | May 02, 1994 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |