K211850 is an FDA 510(k) clearance for the Air Compression Leg Massager (model: FE-7204B). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Healthpal Electronic Co.,Ltd (Xiamen, CN). The FDA issued a Cleared decision on March 3, 2022, 261 days after receiving the submission on June 15, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K211850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2021 |
| Decision Date | March 03, 2022 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |