The following data is part of a premarket notification filed by Shenzhen Lifotronic Technology Co., Ltd. with the FDA for Air Compression Therapy System.
| Device ID | K192466 |
| 510k Number | K192466 |
| Device Name: | Air Compression Therapy System |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Shenzhen Lifotronic Technology Co., Ltd. Unit A, 4th Floor, Building 15, No.1008 Songbai Road Nanshan District Shenzhen, CN 518055 |
| Contact | Xiang Lei |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K, NO. 101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2020-06-22 |