K800917 is an FDA 510(k) clearance for the TRU-COLD THERAPY PAK. This device is classified as a Pack, Hot Or Cold, Reusable (Class I - General Controls, product code IME).
Submitted by Tru-Eze Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1980, 10 days after receiving the submission on April 22, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5700.
| 510(k) Number | K800917 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1980 |
| Decision Date | May 02, 1980 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IME — Pack, Hot Or Cold, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5700 |