The following data is part of a premarket notification filed by Shenzhen Future Electronic Co., Ltd with the FDA for Air Compression Therapy Device, Model: St-502.
| Device ID | K213745 |
| 510k Number | K213745 |
| Device Name: | Air Compression Therapy Device, Model: ST-502 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Shenzhen Future Electronic Co., Ltd Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang District Shenzhen, CN 518116 |
| Contact | Zhao Qihong |
| 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 | 2021-11-29 |
| Decision Date | 2022-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06959557200606 | K213745 | 000 |
| 10810140061239 | K213745 | 000 |