K973023 is an FDA 510(k) clearance for the INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on November 3, 1997, 81 days after receiving the submission on August 14, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K973023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1997 |
| Decision Date | November 03, 1997 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILO — Pack, Hot Or Cold, Water Circulating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5720 |