K955788 is an FDA 510(k) clearance for the IMNI HOT 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 September 4, 1996, 257 days after receiving the submission on December 22, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K955788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1995 |
| Decision Date | September 04, 1996 |
| Days to Decision | 257 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 |