K200660 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 Wonjin Mulsan Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on March 8, 2021, 361 days after receiving the submission on March 12, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K200660 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2020 |
| Decision Date | March 08, 2021 |
| Days to Decision | 361 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 |