K212713 is an FDA 510(k) clearance for the Air compression leg massager HY-1117A. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen High Top Electronic Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on January 18, 2022, 145 days after receiving the submission on August 26, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K212713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2021 |
| Decision Date | January 18, 2022 |
| Days to Decision | 145 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 |