K970533 is an FDA 510(k) clearance for the MODEL 1100 COLD THERAPY DEVICE. This device is classified as a Pack, Hot Or Cold, Water Circulating (Class II - Special Controls, product code ILO).
Submitted by Smith & Nephew, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 15, 1997, 62 days after receiving the submission on February 12, 1997.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5720.
| 510(k) Number | K970533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1997 |
| Decision Date | April 15, 1997 |
| Days to Decision | 62 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 |