The following data is part of a premarket notification filed by Xiamen Healthpal Electronic Co.,ltd with the FDA for Air Compression Leg Massager (model: Fe-7204b).
| Device ID | K211850 |
| 510k Number | K211850 |
| Device Name: | Air Compression Leg Massager (model: FE-7204B) |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Xiamen Healthpal Electronic Co.,Ltd No.170 Siming Park Tongan District, Xiamen City, Fujian Province, China Xiamen, CN 361100 |
| Contact | Henry Zhang |
| Correspondent | Henry Zhang Xiamen Healthpal Electronic Co.,Ltd No.170 Siming Park Tongan District, Xiamen City, Fujian Province, China Xiamen, CN 361100 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-15 |
| Decision Date | 2022-03-03 |