K211283 is an FDA 510(k) clearance for the Compressible Limb and Circulation Therapy System, Model POWER-Q2300. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Wonjin Mulsan Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on September 14, 2021, 140 days after receiving the submission on April 27, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K211283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2021 |
| Decision Date | September 14, 2021 |
| Days to Decision | 140 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 |