K130385 is an FDA 510(k) clearance for the COMPRESSIBLE LIMB SLEEVE SYSTEM. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Maxstar Industrial Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on February 18, 2014, 368 days after receiving the submission on February 15, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K130385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2013 |
| Decision Date | February 18, 2014 |
| Days to Decision | 368 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |