K113275 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB THERAPY SYSTEM. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Wonjin Mulsan Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on February 27, 2012, 115 days after receiving the submission on November 4, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K113275 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2011 |
| Decision Date | February 27, 2012 |
| Days to Decision | 115 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 |