K910061 is an FDA 510(k) clearance for the K-MODULE II HEAT THERAPY SYSTEM. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on February 13, 1991, 35 days after receiving the submission on January 9, 1991.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K910061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1991 |
| Decision Date | February 13, 1991 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |