K181409 is an FDA 510(k) clearance for the Pressure Therapy System PT1003. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Senyang Co., Ltd. (Xinglin Xiamen, CN). The FDA issued a Cleared decision on February 19, 2019, 265 days after receiving the submission on May 30, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K181409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2018 |
| Decision Date | February 19, 2019 |
| Days to Decision | 265 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 |