The following data is part of a premarket notification filed by Xiamen Simo Electronic Co., Ltd with the FDA for Air Pressure Foot Massager.
| Device ID | K212935 |
| 510k Number | K212935 |
| Device Name: | Air Pressure Foot Massager |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Xiamen Simo Electronic Co., Ltd Floor 3rd-5th, No. 173 Siming Park, Tong'an Industrial Zone, Tong'an District Xia Men, CN 361100 |
| Contact | Wang Qinsheng |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD., FangShan District Beijing, CN 102401 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-02-19 |