The following data is part of a premarket notification filed by Xiamen Senyang Co., Ltd. with the FDA for Pressure Therapy System Pt1003.
| Device ID | K192358 |
| 510k Number | K192358 |
| Device Name: | Pressure Therapy System PT1003 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Xiamen Senyang Co., Ltd. 4-5 Floor, Xingbei Industry, No 95-99, West 2 Road Jiu Tianhu Xinglin Xiamen, CN 361000 |
| Contact | Nina Cai |
| Correspondent | Raymond Luo Shanghai SUNGO Management Consultanting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, CN 200122 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-29 |
| Decision Date | 2020-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810113570713 | K192358 | 000 |