K212935 is an FDA 510(k) clearance for the Air Pressure Foot Massager. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Simo Electronic Co., Ltd. (Xia Men, CN). The FDA issued a Cleared decision on February 19, 2022, 157 days after receiving the submission on September 15, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K212935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2021 |
| Decision Date | February 19, 2022 |
| Days to Decision | 157 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 |