K112441 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Daesung Maref Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on January 17, 2012, 146 days after receiving the submission on August 24, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K112441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 2011 |
| Decision Date | January 17, 2012 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |