K940336 is an FDA 510(k) clearance for the CERTI HEAT INSTANT HEAT COMPRESS. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 7, 1994, 41 days after receiving the submission on January 25, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K940336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 1994 |
| Decision Date | March 07, 1994 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |