K954877 is an FDA 510(k) clearance for the OMNI COLD 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 February 13, 1996, 112 days after receiving the submission on October 24, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K954877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | October 24, 1995 |
| Decision Date | February 13, 1996 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |