The following data is part of a premarket notification filed by Xiamen High Top Electronic Technology Co., Ltd. with the FDA for Air Compression Leg Massager Hy-1117a.
| Device ID | K212713 |
| 510k Number | K212713 |
| Device Name: | Air Compression Leg Massager HY-1117A |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Xiamen High Top Electronic Technology Co., Ltd. F2-5 No. 118 Siming Park, Tong'an Industrial Zone Xiamen, CN 361000 |
| Contact | Liangsan Zhao |
| Correspondent | Sam Lin Shanghai Spica Management Consulting Co., Ltd. 609 Room, No.133 Shengang Avenue, Pudong New District Shanghai, CN 201306 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-26 |
| Decision Date | 2022-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850023727074 | K212713 | 000 |
| 10850023727050 | K212713 | 000 |
| 10850023727043 | K212713 | 000 |
| 10850023727036 | K212713 | 000 |