K936084 is an FDA 510(k) clearance for the OMNI WARM GEL PACKS. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Omni Therm, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 31, 1994, 100 days after receiving the submission on December 21, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K936084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1993 |
| Decision Date | March 31, 1994 |
| Days to Decision | 100 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 |