K161907 is an FDA 510(k) clearance for the Pressure Therapy System. 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 23, 2017, 226 days after receiving the submission on July 12, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K161907 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2016 |
| Decision Date | February 23, 2017 |
| Days to Decision | 226 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 |