The following data is part of a premarket notification filed by Huizhou Xinyi Technology Co., Ltd. with the FDA for Yy-a02-b Overlapped Compression Therapy.
| Device ID | K221862 |
| 510k Number | K221862 |
| Device Name: | YY-A02-B Overlapped Compression Therapy |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Huizhou XINYI Technology Co., LTD. Area (Building 3), Changbu Village Xinwei, Huiyang District Huizhou, CN 516200 |
| Contact | Jason Ye |
| Correspondent | Jason Ye Huizhou XINYI Technology Co., LTD. Area (Building 3), Changbu Village Xinwei, Huiyang District Huizhou, CN 516200 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-27 |
| Decision Date | 2022-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06976331789102 | K221862 | 000 |
| 00031262109217 | K221862 | 000 |
| 00031262110534 | K221862 | 000 |
| 00031262108722 | K221862 | 000 |